| SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM (K132929) | Sd Biosensor, Inc. | 2015-08-05 |
| OneTouch Verio Flex Blood Glucose Monitoring System (K150214) | Lifescan Europe | 2015-07-31 |
| TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS (K141289) | Teco Diagnostics | 2015-07-24 |
| ELITech Clinical Systems CALCIUM ARSENAZO (K151113) | Elitechgroup | 2015-07-22 |
| ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material (K143687) | Siemens Healthcare Diagnostics, Inc. | 2015-07-17 |
| Alere i Instrument, Alere i Influenza A & B, Alere i Strep A (K151690) | Alere Scarborough, Inc. | 2015-07-16 |
| Abbott ARCHITECT Total T4 Calibrators (K151566) | Abbott Laboratories | 2015-07-10 |
| ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II (K151552) | Elitechgroup | 2015-07-08 |
| CardioChek Plus Test System (K151530) | Polymer Technology Systems, Inc. | 2015-07-07 |
| ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set (K143075) | Tosoh Bioscience, Inc. | 2015-07-02 |
| LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers (K150879) | DiaSorin, Inc. | 2015-06-22 |
| ABL800 FLEX with AQURE connectivity (K142898) | Radiometer Medical Aps | 2015-06-17 |
| Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) (K140790) | Siemens Healthcare Diagnostics | 2015-06-15 |
| Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System (K141292) | Bionime Coporation | 2015-06-09 |
| VIDAS FT4 (K132058) | Biomerieux S.A. | 2015-06-08 |
| FreeStyle Lite Blood Glucose Monitoring System (K150332) | Abbott Laboratories | 2015-06-05 |
| FreeStyle Freedom Lite Blood Glucose Monitoring System (K150531) | Abbott Laboratories | 2015-06-05 |
| VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II (K142595) | Ortho Clinical Diagnostics | 2015-06-04 |
| GE333 Blood Glucose Monitoring System (K143387) | Bionime Coporation | 2015-06-03 |
| STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A (K141907) | Nova Biomedical Corporation | 2015-05-29 |
| URISCAN OPTIMA (K141874) | Yd Diagnostics Corp. | 2015-05-28 |
| Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls (K140654) | Abbott Laboratories | 2015-05-22 |
| CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM (K140068) | Polymer Technology Systems, Inc. | 2015-05-22 |
| StatStrip Xpress Glucose Hospital Meter System (K150461) | Nova Biomedical Corporation | 2015-05-20 |
| SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM (K141351) | Biotest Medical Corp. | 2015-05-19 |
| MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal) (K151236) | Medtronic Minimed, Inc. | 2015-05-19 |
| Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-30 (K140150) | Hmd Biomedical, Inc. | 2015-05-14 |
| Hematocrit and Metabolite QUALICHECK (K150226) | Radiometer Medical Aps | 2015-05-13 |
| Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control (K142543) | ACON Laboratories, Inc. | 2015-05-11 |
| MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System (K143750) | Apex BioTechnology Corp. | 2015-05-07 |
| FORA GD43 Blood Glucose Monitoring System (K143467) | Taidoc Technology Corporation | 2015-05-07 |
| StatStrip Glucose Hospital Meter (K150281) | Nova Biomedical Corporation | 2015-05-06 |
| ADVIA Centaur TSH3-Ultra (K150403) | Siemens Healthcare Diagnostics, Inc. | 2015-05-01 |
| Elecsys Progesterone III Cal Check 5 (K150955) | Roche Diagnostics | 2015-05-01 |
| BGM009 BLOOD GLUCOSE MONITORING SYSTEM (K141036) | Apex BioTechnology Corp. | 2015-05-01 |
| Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) (K150330) | ACON Laboratories, Inc. | 2015-04-30 |
| VALIDATE Anemia Calibration Verification/ Linearity Test Kit (K142964) | Maine Standards Company, LLC | 2015-04-30 |
| ADVIA CENTAUR TSH (K141999) | Siemens Healthcare Diagnostics, Inc. | 2015-04-22 |
| IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers (K142994) | Immunodiagnostic Systems , Ltd. | 2015-04-21 |
| I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM (K132663) | Alliance International Co., Ltd. | 2015-04-20 |
| i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials (K133002) | Abbott Point of Care, Inc. | 2015-04-16 |
| PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM (K141914) | Ok Biotech Co., Ltd. | 2015-04-15 |
| IMMULITE IGF Control Module, IMMULITE Gastrin Control Module (K150132) | Siemens Healthcare Diagnostics | 2015-04-13 |
| AUTION CHECK PLUS (K142262) | Quantimetrix Corp. | 2015-04-10 |
| Total Bilirubin (K150510) | Abbott Laboratories | 2015-04-02 |
| ADVIA Centaur Cortisol (COR) Assy (K142723) | Siemens Healthcare Diagnostics, Inc. | 2015-03-31 |
| IDS-iSYS CTX-I Calibration Verifiers (K143324) | Immunodiagnostic Systems , Ltd. | 2015-03-30 |
| TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System (K150052) | Nipro Diagnostics, Inc. | 2015-03-26 |
| VARIANT II TURBO HbA1c Kit - 2.0 (K142448) | Bio-Rad Laboratories, Inc. | 2015-03-24 |
| Liquichek Maternal Serum II Control (K143379) | Bio-Rad Laboratories | 2015-03-13 |
| ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM (K141867) | Roche Diagnostics | 2015-03-03 |
| UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator (K142985) | Beckman Coulter, Inc. | 2015-02-26 |
| IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material (K143373) | Siemens Healthcare Diagnostics, Inc. | 2015-02-26 |
| IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material (K143636) | Siemens Healthcare Diagnostics, Inc. | 2015-02-25 |
| ORAGENE DX OGD-500.001 (K141410) | DNA Genotek, Inc. | 2015-02-19 |
| FilmArray 2.0 System (K143178) | Biofire Diagnostics, LLC | 2015-01-30 |
| LDLC3 LDL-Cholesterol Gen.3 (K143691) | Roche Diagnostics Operations (Rdo) | 2015-01-28 |
| ADVIA Centaur IgE Master Curve Material (K143680) | Siemens Healthcare Diagnostics, Inc. | 2015-01-27 |
| IMMULITE 2000 CEA Calibration Verification Material (K143639) | Siemens Healthcare Diagnostics | 2015-01-23 |
| Audit MicroControls Linearity LQ Cystatin-C (K143571) | Aalto Scientific, Ltd. | 2015-01-23 |
| Dexcom Share Direct Secondary Displays (DEN140038) | Dexcom, Inc. | 2015-01-23 |
| Audit MicroControls Linearity FD Tumor Markers II (K143573) | Aalto Scientific, Ltd. | 2015-01-16 |
| IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material (K143504) | Siemens Healthcare Diagnostics, Inc. | 2015-01-14 |
| BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D (K141114) | Bio-Rad Laboratories | 2015-01-09 |
| TIVA (K142946) | Velano Vascular, Inc. | 2015-01-08 |
| IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material (K143352) | Siemens Healthcare Diagnostics, Inc. | 2014-12-24 |
| ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS (K140436) | Fujirebio Diagnostics,Inc. | 2014-12-23 |
| ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material (K143376) | Siemens Healthcare Diagnostics, Inc. | 2014-12-23 |
| Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst (K142373) | Beckman Coulter, Inc. | 2014-12-22 |
| Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) (K142391) | ACON Laboratories, Inc. | 2014-12-22 |
| IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET (K140554) | Immunodiagnostic Systems , Ltd. | 2014-12-19 |
| Elecsys T-Uptake Calset (K143342) | Roche Diagnostics | 2014-12-19 |
| Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno. (K142362) | Beckman Coulter, Inc. | 2014-12-19 |
| ACCU-CHEK AVIVA EXPERT SYSTEM (K142089) | Roche Diagnostics Corporation | 2014-12-17 |
| Elecsys Estradiol III Calcheck (K143284) | Roche Diagnostics | 2014-12-16 |
| AIA-PACK C-Peptide Control Set (K143296) | Tosoh Bioscience, Inc. | 2014-12-16 |
| LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERS (K141463) | DiaSorin, Inc. | 2014-12-10 |
| TOTAL PROTEIN URINE/CSF GEN.3 (K141925) | Roche Diagnostics Operations (Rdo) | 2014-12-09 |
| LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (K140971) | Randox Laboratories Limited | 2014-12-08 |
| ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM) (K143194) | Siemens Healthcare Diagnostics, Inc. | 2014-12-05 |
| ST AIA-PACK PROG II Calibrator Set (K143144) | Tosoh Bioscience, Inc. | 2014-12-03 |
| HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE (K141862) | H2, Inc. | 2014-12-02 |
| DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT (K140859) | Siemens Healthcare Diagnostics, Inc. | 2014-11-26 |
| DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART (K140842) | Siemens Healthcare Diagnostics, Inc. | 2014-11-26 |
| Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity (K143026) | Aalto Scientific, Ltd. | 2014-11-21 |
| Audit MicroControls Linearity LQ Special Diabetes (K142978) | Aalto Scientific, Ltd. | 2014-11-20 |
| PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device (K133303) | Bio-Analysis, Inc. | 2014-11-19 |
| CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT (K140717) | Siemens Healthcare Diagnostics | 2014-11-17 |
| DRAEGER JAUNDICE METER JM-105 (K133175) | Draeger Medical Systems, Inc. | 2014-11-13 |
| ABL90 FLEX (K132691) | Radiometer Medical Aps | 2014-11-13 |
| IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material (K142878) | Siemens Healthcare Diagnostics, Inc. | 2014-10-30 |
| ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM) (K142864) | Siemens Healthcare Diagnostics, Inc. | 2014-10-29 |
| IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM) (K142811) | Siemens Healthcare Diagnostics, Inc. | 2014-10-29 |
| VANTERA CLINICAL ANALYZER (K133849) | Liposcience | 2014-10-22 |
| Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators) (K142220) | Nova Biomedical Corporation | 2014-10-17 |
| ELECSYS FOLATE III (K141426) | Roche Diagnostics | 2014-10-17 |
| BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System (K142302) | Polymer Technology Systems, Inc. | 2014-10-02 |
| FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT) (K140371) | Abbott Diabetes Care, Inc. | 2014-09-30 |
| GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM (K141829) | Ceragem Medisys, Inc. | 2014-09-24 |
| STATSTRIP GLUCOSE HOSPITAL METER SYSTEM (K132121) | Nova Biomedical Corporation | 2014-09-24 |