| GLUCOCARD W Blood Glucose Monitoring System (K170064) | Arkray Factory, Inc. | 2017-08-16 |
| Lumipulse G TSH-III Immunoreaction Cartridges (K171103) | Fujirebio Diagnostics,Inc. | 2017-07-28 |
| Teco Creatinine Enzymatic Reagent Kit (K161527) | Teco Diagnostics, Inc. | 2017-07-21 |
| Dario Blood Glucose Monitoring System (K163159) | Labstyle Innovations, Ltd. | 2017-07-19 |
| MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer (K162698) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2017-07-14 |
| Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System (K163406) | ACON Laboratories, Inc. | 2017-07-11 |
| ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 (K171401) | Elitechgroup | 2017-07-11 |
| GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, (K170143) | Bionime Corporation | 2017-07-06 |
| On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis (K170587) | ACON Laboratories, Inc. | 2017-07-06 |
| ADAMS A1c HA-8180V, CALIBRATOR 80 (K162822) | Arkray Factory, Inc. | 2017-06-29 |
| TransFix/EDTA Vacuum Blood Collection Tubes (K162723) | Caltag Medsystems, Ltd. | 2017-06-22 |
| ePlex Instrument (K163652) | Genmark Diagnostics, Incorporated | 2017-06-09 |
| Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System (K162564) | Tianjin Empecs Medical Device Co., Ltd. | 2017-06-07 |
| Carbon Dioxide Reagent Set (K170200) | Teco Diagnostics, Inc. | 2017-06-01 |
| Creatine Kinase-MB (K162526) | Roche Diagnostics | 2017-05-26 |
| Nova StatSensor Creatinine Hospital Meter System (K171059) | Nova Biomedical Corporation | 2017-05-26 |
| revogene (K170558) | Genepoc, Inc. | 2017-05-25 |
| ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay (K163658) | Siemens Healthcare Diagnostics, Inc. | 2017-05-23 |
| Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder (K163073) | Sol-Millennium Medical, Inc. | 2017-05-19 |
| Vitamin D 200M Assay for the Topaz System (DEN170019) | Ab Sciex, LLC | 2017-05-18 |
| VITROS Immunodiagnostic Products Insulin Calibrators (K171168) | Ortho Clinical Diagnostics | 2017-05-16 |
| iChemVELOCITY Automated Urine Chemistry System (K171083) | Iris Diagnostics, A Division of Iris International, Inc. | 2017-05-12 |
| N Latex Cystatin C; N Protein Standard UY (K171072) | Siemens Healthcare Diagnostics Products GmbH | 2017-05-12 |
| ALP IFCC Gen.2 (K171080) | Roche Diagnostics Operations (Rdo) | 2017-05-10 |
| iGlucose Blood Glucose Monitoring System (K161790) | Bionime Corporation | 2017-05-02 |
| ABL90 FLEX, ABL90 FLEX PLUS (K170882) | Radiometer Medical Aps | 2017-04-28 |
| Randox RX Daytona Plus Magnesium (MG) (K162200) | Randox Laboratories, Ltd. | 2017-04-28 |
| CalSet IGF-1 (K170938) | Roche Diagnostics | 2017-04-26 |
| VivaChek Ino Blood Glucose Monitoring System (K160179) | Vivachek Laboratories, Inc. | 2017-04-21 |
| Randox RX Daytona Plus Alkaline Phosphatase (ALP) (K162275) | Randox Laboratories Limited | 2017-04-21 |
| Smart Dongle Blood Glucose Monitoring System (K162382) | Taidoc Technology Corporation | 2017-04-14 |
| Nova Max Uric Acid Monitoring System (K160990) | Nova Biomedical Corporation | 2017-04-11 |
| i-Stat Alinity System with i-Stat Glucose test (K163271) | Abbott Point of Care, Inc. | 2017-04-10 |
| POGO Automatic Blood Glucose Monitoring System (K162203) | Intuity Medical, Inc. | 2017-04-06 |
| Beta-CrossLaps CalCheck 5 (K170678) | Roche Diagnostics | 2017-04-04 |
| Multichem IA Plus (K162530) | Techno-Path Manufacturing | 2017-03-31 |
| Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System (K152534) | Tianjin Empecs Medical Device Co., Ltd. | 2017-03-21 |
| Direct LDL Cholesterol (LDL) (K161691) | Randox Laboratories Limited | 2017-03-20 |
| LOCI Total Vitamin D Total Assay, LOCI VITD CAL (K162298) | Siemens Healthcare Diagnostics | 2017-03-16 |
| Audit MicroControls Linearity FD Tumor Markers II (K163629) | Aalto Scientific, Ltd. | 2017-03-10 |
| Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) (K161954) | Siemens Healthcare Diagnostics | 2017-03-09 |
| ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) (K170065) | Siemens Healthcare Diagnostics, Inc. | 2017-03-09 |
| BGM009 Plus Blood Glucose Monitoring System (K170267) | Apex BioTechnology Corp. | 2017-03-09 |
| AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System (K153561) | Andon Health Co, Ltd. | 2017-02-16 |
| TAP Blood Collection Device (K161521) | Seventh Sense Biosystems, Inc. | 2017-02-16 |
| Abbott ARCHITECT Free T3 (K170160) | Abbott Laboratories | 2017-02-15 |
| UA-Cellular Complete (K170091) | Streck | 2017-02-09 |
| PIVO (K163508) | Velano Vascular | 2017-02-09 |
| Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 (K162840) | Roche Diagnostics | 2017-02-08 |
| SEEKER System (DEN150035) | Baebies, Inc. | 2017-02-03 |
| IDS-iSYS Intact PTHN (K161158) | Immunodiagnostic Systems , Ltd. | 2017-01-31 |
| Elecsys TSH assay, cobas e 801 Immunoassay analyzer (K162606) | Roche Diagnostics | 2017-01-23 |
| Atellica CH Magnesium (Mg) (K162399) | Siemens Healthcare Diagnostics, Inc. | 2017-01-19 |
| UniStrip1 Generic Blood Glucose Test Strips (K162430) | Ok Biotech Co., Ltd. | 2017-01-19 |
| Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 (K162895) | Roche Diagnostics | 2017-01-18 |
| Lumipulse G FSH-N Calibrators (K163534) | Fujirebio Diagnostics,Inc. | 2017-01-13 |
| Lumipulse G Progesterone-N Calibrators (K163546) | Fujirebio Diagnostics,Inc. | 2017-01-13 |
| FREND Vitamin D Test System (K162754) | Nanoentek USA, Inc. | 2017-01-12 |
| Lumipulse G Prolactin (K163544) | Fujirebio Diagnostics,Inc. | 2017-01-12 |
| Lumipulse G LH Calibrators (K163521) | Fujirebio Diagnostics,Inc. | 2017-01-12 |
| Contour Next EZ Blood Glucose Monitoring System (K162336) | Ascensia Diabetes Care U.S., Inc. | 2017-01-12 |
| Elecsys CYFRA 21-1 CalCheck 5 (K162173) | Roche Diagnostics | 2017-01-12 |
| Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak (K163015) | Bio-Rad Laboratories | 2017-01-10 |
| StatStrip Xpress 2 Glucose Hospital Meter System (K163490) | Nova Biomedical Corporation | 2017-01-06 |
| BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System (K161299) | Apex BioTechnology Corp. | 2016-12-23 |
| Kurin Blood Culture Collection Set (K162233) | Pathway, LLC | 2016-12-23 |
| CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System (K151545) | Polymer Technology Systems, Inc. | 2016-12-22 |
| CardioChek Plus Test System, CardioChek Home Test System (K162282) | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2016-12-22 |
| Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 (DEN150057) | Roche Diagnostics | 2016-12-19 |
| cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay (K160571) | Roche Diagnostics Operations (Rdo) | 2016-12-19 |
| NoCoding1 Plus Blood Glucose Monitoring System (K160742) | I-Sens, Inc. | 2016-12-16 |
| ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer (K161837) | Beckman Coulter, Inc. | 2016-12-16 |
| VITROS Chemistry Products Cl- Slides (K162020) | Ortho Clinical Diagnostics | 2016-12-16 |
| GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) (K160412) | Instrumentation Laboratory CO | 2016-12-14 |
| GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator (K160225) | Instrumentation Laboratory CO | 2016-12-14 |
| GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) (K160402) | Instrumentation Laboratory CO | 2016-12-14 |
| DC-UIBC-CAL (K163078) | Sekisui Diagnostics P.E.I., Inc. | 2016-12-08 |
| Lumipulse G E2-III Calibrators (K163053) | Fujirebio Diagnostics,Inc. | 2016-12-01 |
| EasyLyte Na/K/Cl/Ca Analyzer (K152327) | Medica Corporation | 2016-12-01 |
| One Drop Blood Glucose Monitoring System (K161834) | Agamatrix, Inc. | 2016-11-30 |
| CONTOUR NEXT ONE Blood Glucose Monitoring System (K160682) | Ascensia Diabetes Care | 2016-11-17 |
| ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator (K162538) | Siemens Healthcare Diagnostics | 2016-11-17 |
| StatStrip Xpress Glucose Hospital Meter System (K161856) | Nova Biomedical Corporation | 2016-11-15 |
| IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set (K161831) | Immunodiagnostic Systems , Ltd. | 2016-11-15 |
| Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) (K161494) | Siemens Healthcare Diagnostics, Inc. | 2016-11-15 |
| FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems (K161738) | Taidoc Technology Corporation | 2016-11-10 |
| ABL90 FLEX PLUS (K160153) | Radiometer Medical Aps | 2016-11-04 |
| Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set (K161646) | Diazyme Laboratories | 2016-11-04 |
| Multichem A1c (K162514) | Technopath Manufacturing | 2016-10-26 |
| Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control (K160541) | Sysmex America, Inc. | 2016-10-21 |
| HDL-Cholesterol Gen.4 (K162593) | Roche Diagnostics Operations (Rdo) | 2016-10-19 |
| VITROS® Automation Solutions (K160495) | Ortho-Clinical Diagnostics, Inc. | 2016-10-18 |
| FREND Testosterone Test System (K153577) | Nanoentek USA, Inc. | 2016-10-14 |
| D-10 Hemoglobin A1c Program (K161687) | Bio-Rad Laboratories, Inc. | 2016-10-14 |
| AUTION ELEVEN Semi-Automated Urinalysis System (K160062) | Arkray, Inc. | 2016-10-07 |
| BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System (K160365) | Infopia Co, Ltd. | 2016-09-28 |
| BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube (K160657) | Becton, Dickinson and Company | 2016-09-23 |
| Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set (K161721) | Diazyme Laboratories | 2016-09-20 |
| GEM Premier 3000 (K161818) | Instrumentation Laboratory CO | 2016-09-14 |
| ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II (K153644) | Elitechgroup | 2016-09-07 |