| FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System (K181675) | Taidoc Technology Corporation | 2018-12-10 |
| Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System (K182046) | Tyson Bioresearch, Inc. | 2018-11-30 |
| POPS! one Blood Glucose Monitoring System (K181588) | Taidoc Technology Corporation | 2018-11-30 |
| Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System (K182047) | Tyson Bioresearch, Inc. | 2018-11-29 |
| Afinion HbA1c Dx on Afinion 2 (K182988) | Alere Technologies AS | 2018-11-29 |
| BGM014 Blood Glucose Monitoring System (K182992) | Apex BioTechnology Corp. | 2018-11-28 |
| Elecsys Tacrolimus (K173857) | Roche Diagnostics | 2018-11-06 |
| Dexcom Pro Q Continuous Glucose Monitoring System (K182405) | Dexcom, Inc. | 2018-11-02 |
| GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System (K181273) | I-Sens, Inc. | 2018-11-01 |
| VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System (K182063) | Ortho-Clinical Diagnostics, Inc. | 2018-10-30 |
| VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides (K182072) | Ortho-Clinical Diagnostics, Inc. | 2018-10-30 |
| Dexcom G6 Glucose Program Continuous Glucose Monitoring System (K182041) | Dexcom, Inc. | 2018-10-26 |
| picoAMH ELISA (DEN180004) | Ansh Labs, LLC | 2018-10-24 |
| Randox Calcium (Ca) (K182042) | Randox Laboratories, Ltd. | 2018-10-23 |
| Extended Lipid Panel Assay (K181373) | Laboratory Corporation of America Holdings | 2018-10-18 |
| MAGLUMI 2000 FT4 (K182423) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2018-10-04 |
| On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System (K181527) | ACON Laboratories, Inc. | 2018-10-03 |
| Stat Profile Prime Plus Analyzer System (K180340) | Nova Biomedical Corporation | 2018-09-26 |
| Oh'Care Lite Smart Blood Glucose Monitoring System (K182286) | Osang Healthcare Co. , Ltd. | 2018-09-19 |
| Elecsys FT4 III (K181233) | Roche Diagnostics | 2018-09-18 |
| Magnesium (K181748) | Abbott Laboratories | 2018-09-12 |
| NeoBase 2 Non-derivatized MSMS Kit (K173568) | Wallac Oy, Subsidiary of Perkinelmer, Inc. | 2018-09-04 |
| CareSens S Fit Blood Glucose Monitoring System (K180866) | I-Sens, Inc. | 2018-08-31 |
| EasyMax BT Self-Monitoring Blood Glucose System (K182057) | Eps Bio Technology Corp. | 2018-08-24 |
| Confidence Blood Glucose Monitoring System (K173658) | Applied Biomedical, LLC | 2018-08-21 |
| Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus (K173638) | Bionime Corporation | 2018-08-17 |
| Stat Profile Prime Plus Analyzer System (K180428) | Nova Biomedical Corporation | 2018-08-15 |
| FORA GTel Blood Glucose Monitoring System (K173505) | Foracare, Inc. | 2018-08-09 |
| Free Testosterone AccuBind ELISA Test System (K181017) | Monobind, Inc. | 2018-07-20 |
| Atellica IM High-Sensitivity Troponin I (TNIH) (K171566) | Siemens Healthcare Diagnostics, Inc. | 2018-07-19 |
| DIP/U.S. Urine Analysis Test System (K173327) | Healthy.Io, Ltd. | 2018-07-18 |
| NeoLSD MSMS kit (K173829) | Wallac Oy, A Subsidiary of Perkinelmer | 2018-07-18 |
| Stat Profile Prime Plus Analyzer System (K173797) | Nova Biomedical Corporation | 2018-07-17 |
| Dimension Hemoglobin A1c Assay (K173909) | Siemens Healthcare Diagnostics, Inc. | 2018-07-13 |
| StatStrip Glucose Hospital Meter System (K181043) | Nova Biomedical Corporation | 2018-07-12 |
| ADVIA Centaur High-Sensitivity Troponin I (TNIH) (K171274) | Siemens Healthcare Diagnostics, Inc. | 2018-07-12 |
| ActiveCare TD-4121 Blood Glucose Monitoring System (K173511) | Taidoc Technology Corporation | 2018-07-12 |
| SEKURE HbA1c Assay (K173206) | Sekisui Diagnostics P.E.I., Inc. | 2018-07-12 |
| Synermed ISE Reagents (K181201) | Infrared Laboratory Systems, LLC (Dba Synermed) | 2018-07-10 |
| BioPlex 2200 25-OH Vitamin D Kit (K180577) | Bio-Rad Laboratories | 2018-06-22 |
| Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus (K173139) | Bionime Corporation | 2018-06-19 |
| POGO Automatic Blood Glucose Monitoring System (K181316) | Intuity Medical, Inc. | 2018-06-14 |
| Access hsTnl (K172787) | Beckman Coulter, Inc. | 2018-06-14 |
| DreaMed Advisor Pro (DEN170043) | DreaMed Diabetes, Ltd. | 2018-06-12 |
| Access hs Tnl (K172783) | Beckman Coulter, Inc. | 2018-06-12 |
| Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder (K172763) | Zhejiang Kindly Medical Devices Co., Ltd. | 2018-06-04 |
| ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) (K181082) | Siemens Healthcare Diagnostics, Inc. | 2018-05-25 |
| inui In-Home Urine Analysis Test System (K180356) | Scanadu, Inc. | 2018-05-25 |
| DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips (K181024) | DFI Co., Ltd. | 2018-05-23 |
| Magnesium (K173294) | Abbott Laboratories | 2018-05-18 |
| Acro HCG Pregnancy Rapid Test (K180771) | Acro Biotech, Inc. | 2018-05-18 |
| Afinion HbA1c Dx (K180296) | Alere Technologies AS | 2018-05-07 |
| TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System (K173345) | Taidoc Technology Corporation | 2018-05-04 |
| KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System (K170463) | I-Sens, Inc. | 2018-04-13 |
| ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 (K170901) | Biosystems S.A. | 2018-04-13 |
| Atellica IM Folate Assay (K172201) | Siemens Healthcare Diagnostics, Inc. | 2018-04-12 |
| Atellica IM Total hCG (ThCG) (K172322) | Siemens Healthcare Diagnostics, Inc. | 2018-03-29 |
| Mission Lipid Panel Monitoring System (K180504) | ACON Laboratories, Inc. | 2018-03-28 |
| David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette (K172627) | Runbio Biotech Co.,Ltd | 2018-03-28 |
| Dexcom G6 Continuous Glucose Monitoring System (DEN170088) | Dexcom, Inc. | 2018-03-27 |
| Dario LC Blood Glucose Monitoring System (K172723) | Labstyle Innovation, Ltd. | 2018-03-23 |
| Preview Digital Pregnancy Test (K173229) | Guangzhou Wondfo Biotech Co., Ltd. | 2018-03-12 |
| On Call Express Mobile Blood Glucose Monitoring System (K180196) | ACON Laboratories, Inc. | 2018-03-07 |
| SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) (K171476) | Awareness Technology, Inc. | 2018-02-27 |
| DUS R-50S (Urine Chemistry system) (K171521) | DFI Co., Ltd. | 2018-02-16 |
| CAPILLARYS Hb A1c (K171861) | Sebia | 2018-02-07 |
| ACRO HCG Pregnancy Rapid Test (K172512) | Acro Biotech, Inc. | 2018-02-02 |
| Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer (K171971) | Lite-On Technology Corp. H.S.P.B. | 2018-01-25 |
| epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test (K171247) | Epocal, Inc. | 2018-01-17 |
| Diazyme EZ Vitamin D Assay (K172992) | Diazyme Laboratories | 2018-01-11 |
| GEM Premier 5000 (K173403) | Instrumentation Laboratory CO | 2017-12-29 |
| TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format) (K172257) | True Diagnostics, Inc. | 2017-12-22 |
| NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System (K171480) | I-Sens, Inc. | 2017-12-13 |
| ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay (K171771) | Siemens Healthcare Diagnostics, Inc. | 2017-12-04 |
| LIA Pregnancy Test (K171136) | Lia Diagnostics | 2017-11-20 |
| NEPHROCHECK Test System (K171482) | Astute Medical, Inc. | 2017-11-16 |
| Access AMH (K170524) | Beckman Coulter, Inc. | 2017-11-13 |
| StatStrip Xpress Blood Glucose Monitoring System (K170464) | Nova Biomedical Corporation | 2017-11-07 |
| PixoTest Blood Glucose Monitoring System (K163087) | Ixensor Company , Ltd. | 2017-11-02 |
| ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay (K172133) | Axis-Shield Diagnostics, Ltd. | 2017-10-27 |
| Abbott Architect Free T4 (K173122) | Abbott Laboratories | 2017-10-27 |
| Alinity c ICT Sample Diluent (K170320) | Abbott Laboratories | 2017-10-24 |
| Alinity i Total ß-hCG Reagent Kit, Alinity i System (K170317) | Abbott Laboratories | 2017-10-23 |
| ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM (K170316) | Abbott Laboratories | 2017-10-19 |
| CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System (K170614) | I-Sens, Inc. | 2017-10-19 |
| SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System (K160282) | Sd Biosensor | 2017-10-17 |
| GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System (K170241) | All Medicus Co., Ltd. | 2017-10-13 |
| AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer (K170232) | Boditech Med, Inc. | 2017-10-13 |
| Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System (K170079) | Tyson Bioresearch, Inc. | 2017-10-06 |
| Gold AQ Blood Glucose Monitoring System (K170264) | Changsha Sinocare, Inc. | 2017-10-05 |
| FreeStyle Precision Neo Blood Glucose Test Strips (K171941) | Abbott Diabetes Care, Inc. | 2017-09-27 |
| Scanostics UTI Check Application Test System (K170118) | Teco Diagnostics | 2017-09-21 |
| AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX (K163462) | Radiometer Medical Aps | 2017-09-21 |
| NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) (K171822) | Biotest Medical Corporation | 2017-09-20 |
| VITROS Chemistry Products GLU Slides (K163433) | Ortho Clinical Diagnostics | 2017-09-18 |
| iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5) (K170231) | Andon Health Co, Ltd. | 2017-09-15 |
| WowGoHealth Blood Glucose Monitoring System (K171785) | Biotest Medical Corporation | 2017-09-15 |
| CAPI 3 Hb A1c (K171537) | Sebia | 2017-09-12 |
| Diazyme DZ-Lite Total beta-hCG Test System (K163418) | Diazyme Laboratories | 2017-08-18 |
| s LDL-EX SEIKEN (K161679) | Denka Seiken Co., Ltd. | 2017-08-18 |