| Basal-IQ Technology (K193483) | Tandem Diabetes Care, Inc. | 2020-02-28 |
| Proov Test (K191462) | Mfb Fertility, Inc. | 2020-02-27 |
| Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer (K191030) | Life Technologies Corporation | 2020-02-21 |
| OneTouch Verio Reflect Blood Glucose Monitoring System (K193475) | Lifescan Europe GmbH | 2020-02-14 |
| i-STAT CHEM8+ cartridge with the i-STAT 1 System (K191360) | Abbott Point of Care, Inc. | 2020-02-14 |
| NeoBase 2 Non-derivatized MSMS Kit (K193103) | Perkinelmer, Inc. | 2020-02-07 |
| i-STAT CHEM8+ cartridge with the i-STAT 1 System (K183688) | Abbott Point of Care, Inc. | 2020-02-07 |
| i-STAT CHEM8+ cartridge with the i-STAT 1 System (K183678) | Abbott Point of Care, Inc. | 2020-02-07 |
| i-STAT CHEM8+ cartridge with the i-STAT 1 System (K191298) | Abbott Point of Care, Inc. | 2020-02-07 |
| Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223) (K191832) | Kurin, Inc. | 2020-02-04 |
| Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System (K193642) | Dexcom, Inc. | 2020-01-29 |
| CareSens S Clear BT Blood Glucose Monitoring System (K192859) | I-Sens, Inc. | 2020-01-24 |
| Stat Profile Prime Plus Analyzer System (K193246) | Nova Biomedical Corporation | 2020-01-24 |
| PIVO(TM) (K193569) | Velano Vascular | 2020-01-21 |
| CareSens S Fit BT Blood Glucose Monitoring System (K193590) | I-Sens, Inc. | 2020-01-17 |
| MAGLUMI 2000 HCG/ß-HCG (K192547) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2020-01-17 |
| Oragene®•Dx (K192920) | DNA Genotek, Inc. | 2020-01-14 |
| ACTIVE® Free Testosterone RIA (K191350) | Immunotech S.R.O. | 2019-12-20 |
| Albumin BCP (K193001) | SENTINEL CH. SpA | 2019-12-19 |
| ReliOn Premier Classic Blood Glucose Monitoring System (K192220) | I-Sens, Inc. | 2019-12-13 |
| Control-IQ Technology (DEN190034) | Tandem Diabetes Care, Inc. | 2019-12-13 |
| GSP Neonatal Creatine Kinase - MM kit (DEN180056) | Perkinelmer, Inc. | 2019-12-12 |
| CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream (K193132) | Hangzhou Clongene Biotech Co., Ltd. | 2019-12-11 |
| ADVIA Centaur Cortisol (COR) (K192788) | Siemens Healthcare Diagnostics, Inc. | 2019-11-25 |
| INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream (K192843) | Innovita (Tangshan) Biological Technology Co., Ltd. | 2019-11-22 |
| CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System (K191286) | Ascensia Diabetes Care | 2019-11-08 |
| GSP Neonatal Total Galactose kit (K190335) | Perkinelmer, Inc. | 2019-11-06 |
| TAP Blood Collection Device (K190225) | Seventh Sense Biosystems, Inc. | 2019-11-05 |
| MDT2 BLE Self-Monitoring Blood Glucose System (K190189) | Eps Bio Technology Corp. | 2019-11-01 |
| Atellica IM Total hCG (ThCG) (K192790) | Siemens Healthcare Diagnostics, Inc. | 2019-10-30 |
| Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System (K192787) | Dexcom, Inc. | 2019-10-25 |
| On Call Express II Blood Glucose Monitoring System (K192175) | ACON Laboratories, Inc. | 2019-10-17 |
| Dexcom G6 Pro Continuous Glucose Monitoring System (K191833) | Dexcom, Inc. | 2019-10-07 |
| DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 (K190298) | Beckman Coulter Biomedical GmbH | 2019-10-04 |
| LIAISON Vitamin B12 (K192064) | DiaSorin, Inc. | 2019-10-02 |
| Omnipod DASH Insulin Management System with interoperable technology (K191679) | Insulet Corporation | 2019-09-20 |
| ARCHITECT STAT High Sensitivity Troponin-I (K191595) | Abbott Laboratories Diagnostics Division | 2019-09-13 |
| HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream (K192123) | Qingdao Hightop Biotech Co., Ltd. | 2019-09-05 |
| Lumipulse G whole PTH (K190702) | Fujirebio Diagnostics,Inc. | 2019-08-30 |
| Yumizen C1200 ALP, Yumizen C1200 Albumin (K191245) | HORIBA ABX SAS | 2019-08-30 |
| ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG (K191533) | Siemens Healthcare Diagnostics, Inc. | 2019-08-28 |
| Stat Profile Prime ES Comp Plus Analyzer System (K191626) | Nova Biomedical Corporation | 2019-08-16 |
| Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions (K191899) | Roche Diagnostics | 2019-08-16 |
| MAGLUMI 2000 25-OH Vitamin D (K191499) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2019-08-01 |
| Atellica CH Amylase_2 (AMY_2) (K191454) | Siemens Healthcare Diagnostics, Inc. | 2019-07-30 |
| Blood Transfer Accessory (BTA) (K181743) | Nsp Tech Pte, Ltd. | 2019-07-30 |
| Blood Collection Accessory (BUCA) (K181754) | Nsp Tech Pte, Ltd. | 2019-07-30 |
| Quantisal II Oral Fluid Collection Device (K183048) | Immunalysis Corporation | 2019-07-29 |
| ACR LAB Urine Analysis Test System (K182384) | Healthy.Io, Ltd. | 2019-07-26 |
| Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe (K191396) | HORIBA ABX SAS | 2019-07-26 |
| Stat Profile Prime ES Comp Plus Analyzer System (K191365) | Nova Biomedical Corporation | 2019-07-19 |
| DreaMed Advisor Pro (K191370) | DreaMed Diabetes, Ltd. | 2019-07-18 |
| Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) (K190485) | Kawasumi Laboratories, Inc. | 2019-07-08 |
| Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System (K191450) | Dexcom, Inc. | 2019-06-28 |
| IDS SHBG (K190121) | Immunodiagnostic Systems , Ltd. | 2019-06-17 |
| LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 (K172232) | Ams Diagnostics | 2019-06-12 |
| On Call Express Voice Blood Glucose Monitoring System (K191038) | ACON Laboratories, Inc. | 2019-06-12 |
| VITROS XT Chemistry Products ALB-TP Slides (K191316) | Ortho-Clinical Diagnostics, Inc. | 2019-06-07 |
| TD-4183 Blood Glucose Monitoring System (K190579) | Taidoc Technology Corporation | 2019-06-04 |
| Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB (K190564) | Bionime Corporation | 2019-06-02 |
| PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System (K183205) | Emcyte Corporation | 2019-05-30 |
| Dimension EXL High-Sensitivity Troponin I (TNIH) Assay (K190675) | Siemens Healthcare Diagnostics, Inc. | 2019-05-17 |
| VeriClear Digital Early Result Pregnancy Test (K182328) | True Diagnostics, Inc. | 2019-05-15 |
| PIVO (K190604) | Velano Vascular | 2019-05-13 |
| GlucoLeader Enhance Blood Glucose Monitoring System (K182428) | Hmd Biomedical, Inc. | 2019-05-08 |
| cobas u 601 urinalysis test system (K183432) | Roche Diagnostics | 2019-05-07 |
| NeoLSD MSMS Kit (K190266) | Perkinelmer, Inc. | 2019-05-03 |
| alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL (K182474) | Biosystems S.A. | 2019-05-02 |
| VITROS XT Chemistry Products TBIL-ALKP Slides (K190807) | Ortho-Clinical Diagnostics, Inc. | 2019-04-26 |
| SEKURE Creatine Kinase Assay (K182702) | Sekisui Diagnostics P.E.I., Inc. | 2019-04-17 |
| Elecsys TSH (K190773) | Roche Diagnostics | 2019-04-16 |
| WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream (K190705) | Wholepower Biotech Co., Ltd. | 2019-04-15 |
| GLUCOCARD® W onyx Blood Glucose Monitoring System (K183306) | Arkray Factory, Inc. | 2019-04-10 |
| VITROS XT Chemistry Products GLU-Ca Slides (K190520) | Ortho-Clinical Diagnostics, Inc. | 2019-04-03 |
| VITROS XT Chemistry Products TRIG-CHOL Slides (K190490) | Ortho-Clinical Diagnostics, Inc. | 2019-03-27 |
| VITROS XT Chemistry Products UREA-CREA Slides (K190326) | Ortho-Clinical Diagnostics, Inc. | 2019-03-14 |
| Dimension Vista High-Sensitivity Troponin I (TNIH) Assay (K182225) | Siemens Healthcare Diagnostics, Inc. | 2019-03-04 |
| DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette (K181551) | Runbio Biotech Co.,Ltd | 2019-02-22 |
| GEM Premier ChemSTAT (K183555) | Instrumentation Laboratory CO | 2019-02-16 |
| GEM Premier ChemSTAT (K183546) | Instrumentation Laboratory CO | 2019-02-16 |
| GEM Premier ChemSTAT (K183549) | Instrumentation Laboratory CO | 2019-02-16 |
| t:slim X2 insulin pump with interoperable technology (DEN180058) | Tandem Diabetes Care, Inc. | 2019-02-14 |
| Dexcom G6 Continuous Glucose Monitoring System (K183206) | Dexcom, Inc. | 2019-02-14 |
| Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode (K183375) | Horiba, Ltd. | 2019-02-12 |
| Ammonia II (K183517) | Roche Diagnostics Operations (Rdo) | 2019-02-08 |
| iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) (K181070) | Andon Health Co, Ltd. | 2019-02-01 |
| FastPack IP Sex Hormone Binding Globulin Immunoassay (K182521) | Qualigen, Inc. | 2019-01-29 |
| MiniCollect K2E K2EDTA Tubes (K182078) | Greiner Bio-One Na, Inc. | 2019-01-25 |
| Kurin PIV Blood Collection Set with High Pressure (K181895) | Kurin, Inc. | 2019-01-18 |
| HbA1c Advanced (K182651) | Beckman Coulter Ireland, Inc. | 2019-01-16 |
| Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream (K183097) | Weihai Kangzhou Biotechnology Engineering Co., Ltd. | 2019-01-10 |
| Miris Human Milk Analyzer (DEN180007) | Miris AB | 2018-12-21 |
| ADVIA Centaur Calcitonin (CALCT) assay (K182012) | Axis-Shield Diagnostics Limited | 2018-12-21 |
| PTS Professional Chemistry Kit (K182781) | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2018-12-21 |
| VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System (K173140) | Vivachek Laboratories, Inc. | 2018-12-19 |
| KET-1 Blood Ketone Monitoring System (K182593) | Apex BioTechnology Corp. | 2018-12-18 |
| StatStrip Xpress Glucose Hospital Meter System (K182552) | Nova Biomedical Corporation | 2018-12-13 |
| Accu-Chek Guide Me Blood Glucose Monitoring System (K181131) | Roche Diabetes Care | 2018-12-13 |
| StatStrip Xpress 2 Glucose Hospital Meter System (K182549) | Nova Biomedical Corporation | 2018-12-13 |
| URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer (K182038) | Yd Diagnostics Corporation | 2018-12-10 |