| HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST (K120945) | Hitachi Chemical Diagnostics, Inc. | 2013-06-07 |
| HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) (K131051) | Hitachi Chemical Diagnostics, Inc. | 2013-06-07 |
| S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN (K131217) | Hitachi Chemical Diagnostics, Inc. | 2013-06-07 |
| VITROS CHEMISTRY PRODUCTS TRIG SLIDES (K130332) | Ortho-Clinical Diagnostics, Inc. | 2013-05-31 |
| GLUCOSE METER-CHECK SOLUTION FOR TAIDOC (K131136) | Bionostics, Inc. | 2013-05-31 |
| CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST (K123844) | Chemtron Biotech, Inc. | 2013-05-30 |
| TINA-QUANT HBA1C GEN. 2 TEST SYSTEM (DEN130002) | Roche Diagnostics | 2013-05-23 |
| COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 (K123726) | Roche Diagnostics | 2013-05-21 |
| ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT (K123322) | Alfa Wassermann Diagnostics Technologies, LLC | 2013-05-21 |
| FORACARE GD20 BLOOD GLUCOSE MONITORING SYSTEM (K124040) | Taidoc Technology Corporation | 2013-05-16 |
| EASYRA CREATININE REAGENT (K123586) | Medica Corporation | 2013-05-15 |
| VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III (K123930) | Ortho-Clinical Diagnostics, Inc. | 2013-05-15 |
| ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE (K120615) | Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen | 2013-05-15 |
| ABL90 FLEX (K123748) | Radiometer Medical Aps | 2013-05-07 |
| LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK (K130963) | Bio-Rad Laboratories, Inc. | 2013-05-06 |
| ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT (K123953) | Alfa Wassermann Diagnostic Technologies, Inc. | 2013-05-02 |
| HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) (K130870) | Hitachi Chemical Diagnostics, Inc. | 2013-05-02 |
| SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM (K122525) | Biotest Medical Corp. | 2013-05-02 |
| AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET (K130762) | Aalto Scientific, Ltd. | 2013-04-29 |
| AUDIT MICROCV VITAMIN D LINEARITY SET (K130764) | Aalto Scientific, Ltd. | 2013-04-26 |
| GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION (K130886) | Glooko, Inc. | 2013-04-25 |
| TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM (K120989) | Nipro Diagnostics, Inc. | 2013-04-24 |
| ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE (K123018) | Alfa Wassermann Diagnostic Technologies, Inc. | 2013-04-23 |
| MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM (K122539) | Siemens Healthcare Diagnostics | 2013-04-19 |
| MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C (K124009) | Diamond Diagnostics, Inc. | 2013-04-17 |
| IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION (K130535) | Agamatrix, Inc. | 2013-04-17 |
| LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK (K130761) | Bio-Rad Laboratories | 2013-04-12 |
| IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM (K123935) | Andon Medical Co., Ltd. | 2013-04-12 |
| HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE) (K123703) | Healgen Scientific,, LLC | 2013-04-10 |
| LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS (K130321) | Diasorin | 2013-04-09 |
| LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3 (K130469) | DiaSorin, Inc. | 2013-04-05 |
| DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL) (K130698) | Siemens Healthcare Diagnostics | 2013-04-05 |
| DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITORING SYSTEM (K122307) | Biocare Corporation | 2013-04-05 |
| FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001 (K123089) | Abbott Laboratories | 2013-04-05 |
| ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II (K130765) | Elitechgroup | 2013-04-04 |
| NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR (K122688) | Nova Biomedical Corporation | 2013-04-04 |
| LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3 (K121951) | DiaSorin, Inc. | 2013-04-04 |
| CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC (K121823) | Wescor, Inc. | 2013-03-27 |
| HIGH METABOLITE QUALICHECK (K130415) | Radiometer Medical Aps | 2013-03-26 |
| AXIS-SHIELD ACVTIVE-B12 (K121946) | Axis-Shield Diagnostics, Ltd. | 2013-03-22 |
| DIMENSION EXL WITH LM SYSTEM (K130276) | Siemens Healthcare Diagnostics, Inc. | 2013-03-22 |
| S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) (K130141) | Hitachi Chemical Diagnostics, Inc. | 2013-03-22 |
| ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY (K121981) | Siemens Healthcare Diagnostics | 2013-03-21 |
| AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET (K130157) | Aalto Scientific, Ltd. | 2013-03-19 |
| RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 (K130236) | Radiometer Medical Aps | 2013-03-15 |
| SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM (K130138) | Roche Diagnostics Corp. | 2013-03-15 |
| FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER (K122907) | Polymed Therapeutics, Inc. | 2013-03-14 |
| IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL (K122534) | Siemens Healthcare Diagnostics, Inc. | 2013-03-14 |
| PERKINELMER 226 SAMPLE COLLECTION DEVICES (K121864) | Perkinelmer, Inc. | 2013-03-12 |
| PICCOLO LACTATE TEST SYSTEM (K130113) | Abaxis, Inc. | 2013-03-11 |
| BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE) (K113636) | Philosys Co., Ltd. | 2013-03-08 |
| FASTPACK CONTROL KIT (K123725) | Qualigen, Inc. | 2013-03-08 |
| QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT (K123955) | Life Technologies Corporation | 2013-03-08 |
| GENESIS HEALTH RECORD SYSTEM, (GHRS) (K123136) | Genesis Health Technologies | 2013-03-07 |
| DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) (K123677) | Siemens Healthcare Diagnostics | 2013-03-07 |
| EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT (K123802) | Medica Corp. | 2013-03-01 |
| LIQUID ASSAYED MULTIQUAL PREMIUM (K130162) | Bio-Rad Laboratories | 2013-03-01 |
| COBAS INTEGRA BILIRUBIN DIRECT GEN.2 (K123965) | Roche Diagnostics | 2013-02-28 |
| ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL (K122177) | Elitechgroup | 2013-02-15 |
| PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM (K130200) | Abaxis, Inc. | 2013-02-15 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS (K121608) | Ortho-Clinical Diagnostics, Inc. | 2013-02-15 |
| DIMENSION AMMONIA FLEX REAGENT CARTRIDGE (K123320) | Siemens Healthcare Diagnostics | 2013-02-15 |
| DIMENSION CHEMISTRY III CALIBRATORY (K123321) | Siemens Healthcare Diagnostics | 2013-02-15 |
| GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK (K123851) | Bionostics, Inc. | 2013-02-14 |
| GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS (K121433) | Hmd Biomedical, Inc. | 2013-02-14 |
| ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM (K113614) | Roche Diagnostics | 2013-02-12 |
| LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM (K102751) | Ceragem Medisys, Inc. | 2013-02-11 |
| ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI (K123131) | Tosoh Bioscience, Inc. | 2013-02-08 |
| ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION (K120558) | Lifescan, Inc. | 2013-02-07 |
| ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM (K120708) | Cilag GmbH International | 2013-02-07 |
| EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II) (K123050) | Nantong Biotechnology Co., Ltd. | 2013-02-05 |
| ARCHITECT TOTAL BILIRUBIN (K121985) | Abbott Laboratories | 2013-02-01 |
| AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL (K121456) | Arkray, Inc. | 2013-02-01 |
| LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK (K123775) | Bio-Rad Laboratories | 2013-01-31 |
| RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN (K123008) | Bionime Corporation | 2013-01-25 |
| LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET (K122793) | DiaSorin, Inc. | 2013-01-25 |
| GLUCOSE METER-CHECK SOLUTION FOR BAYER (K123966) | Bionostics, Inc. | 2013-01-25 |
| FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA (K123612) | Fujirebio Diagnostics,Inc. | 2013-01-17 |
| ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR (K123372) | Abbott Laboratories | 2013-01-14 |
| FORA V10 BLOOD GLUCOSE MONITORING SYSTEM (K121706) | Foracare, Inc. | 2013-01-14 |
| BLOOD CULTURE HOLDER (K122687) | Greiner Bio-One North America, Inc. | 2013-01-10 |
| LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P (K121399) | Luminex Corp. | 2013-01-09 |
| LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK (K123798) | Bio-Rad Laboratories | 2013-01-09 |
| LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT (K121944) | DiaSorin, Inc. | 2013-01-01 |
| QUICK SAMPLER HOLDER (K120490) | Nipro Medical Corporation | 2012-12-27 |
| LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK (K123663) | Bio-Rad Laboratories | 2012-12-27 |
| GLOOKO LOGBOOK CHARTS (K122142) | Glooko, Inc. | 2012-12-21 |
| DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH (K121027) | Diamond Diagnostics, Inc. | 2012-12-20 |
| NOVA ONE BLOOD GLUCOSE MONITOR (K122435) | Nova Biomedical Corporation | 2012-12-20 |
| ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM (K123010) | ACON Laboratories, Inc. | 2012-12-14 |
| DA01 BLOOD GLUCOSE MONITORING SYSTEM (K120866) | Delbio Incorporation | 2012-12-11 |
| BLOOD GLUCOSE MONITORING SYSTEM (K120813) | Andon Medical Co., Ltd. | 2012-12-07 |
| ELECSYS CA 15-3 II CALCHECK 5 (K122242) | Roche Diagnostics | 2012-12-05 |
| GENSTRIP TEST STRIP MODEL 100-201 (K103542) | Shasta Technologies, LLC | 2012-11-30 |
| DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR (K121994) | Siemens Healthcare Diagnostics, Inc. | 2012-11-30 |
| DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA (K122420) | Diazyme Laboratories | 2012-11-28 |
| ABBOTT ARCHITECT FREE T4 (K123379) | Abbott Laboratories | 2012-11-27 |
| AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE (K120326) | Radiometer Medical Aps | 2012-11-21 |
| ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM (K122110) | ACON Laboratories, Inc. | 2012-11-21 |
| RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3 (K121603) | Randox Laboratories, Ltd. | 2012-11-20 |