| ABL90 FLEX PLUS System (K252488) | Radiometer Medicals Aps | 2026-05-01 |
| YSI 2900C Biochemistry Analyzer (K210933) | Ysi, Inc. | 2024-09-30 |
| EasyStat 300 (K220328) | Medica Corporation | 2024-07-26 |
| Cholestech LDX ™ System (K223179) | Alere San Diego, Inc. | 2023-09-20 |
| i-STAT G cartridge with the i-STAT 1 System (K223755) | Abbott Point of Care, Inc. | 2023-09-11 |
| i-STAT CG8+ cartridge with the i-STAT 1 System (K223710) | Abbott Point of Care, Inc. | 2023-07-28 |
| GEM Premier ChemSTAT (K223090) | Instrumentation Laboratory CO | 2023-01-27 |
| Nova Primary Glucose Analyzer System (K203549) | Nova Biomedical Corporation | 2022-10-18 |
| i-STAT CHEM8+ cartridge with the i-STAT 1 System (K210958) | Abbott Point of Care, Inc. | 2021-08-13 |
| Stat Profile Prime Plus Analyzer System (K200349) | Nova Biomedical Corporation | 2020-03-13 |
| i-STAT CHEM8+ cartridge with the i-STAT 1 System (K183678) | Abbott Point of Care, Inc. | 2020-02-07 |
| VITROS XT Chemistry Products GLU-Ca Slides (K190520) | Ortho-Clinical Diagnostics, Inc. | 2019-04-03 |
| GEM Premier ChemSTAT (K183546) | Instrumentation Laboratory CO | 2019-02-16 |
| PTS Professional Chemistry Kit (K182781) | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2018-12-21 |
| Stat Profile Prime Plus Analyzer System (K180340) | Nova Biomedical Corporation | 2018-09-26 |
| VITROS Chemistry Products GLU Slides (K163433) | Ortho Clinical Diagnostics | 2017-09-18 |
| i-Stat Alinity System with i-Stat Glucose test (K163271) | Abbott Point of Care, Inc. | 2017-04-10 |
| CardioChek Plus Test System, CardioChek Home Test System (K162282) | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2016-12-22 |
| GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) (K160402) | Instrumentation Laboratory CO | 2016-12-14 |
| GEM Premier 3000 (K161818) | Instrumentation Laboratory CO | 2016-09-14 |
| Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer (K153692) | Infrared Laboratory Systems, LLC (Dba Synermed) | 2016-06-24 |
| ABL80 FLEX and ABL80 FLEX CO-OX (K151639) | Sendx Medical, Inc. | 2015-12-07 |
| GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System (K142689) | Apex BioTechnology Corp. | 2015-08-06 |
| CardioChek Plus Test System (K151530) | Polymer Technology Systems, Inc. | 2015-07-07 |
| MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System (K143750) | Apex BioTechnology Corp. | 2015-05-07 |
| 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 |
| GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System (K142336) | Arkray Factory, Inc. | 2014-09-17 |
| IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM (K133584) | Eoshealth, Inc. | 2014-09-08 |
| ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM (K124021) | Arkray Factory, Inc. | 2014-06-30 |
| AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM (K131750) | Apex BioTechnology Corp. | 2014-03-06 |
| ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE (K120615) | Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen | 2013-05-15 |
| BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE) (K113636) | Philosys Co., Ltd. | 2013-03-08 |
| FORA V10 BLOOD GLUCOSE MONITORING SYSTEM (K121706) | Foracare, Inc. | 2013-01-14 |
| ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM (K122110) | ACON Laboratories, Inc. | 2012-11-21 |
| AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION (K121654) | I-Sens, Inc. | 2012-09-05 |
| CLEVER CHOICE (K120921) | Simple Diagnostics, Inc. | 2012-08-21 |
| CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION (K120759) | I-Sens, Inc. | 2012-06-05 |
| ELEMENT BLOOD GLUCOSE MONITORING SYSTEM (K113670) | Infopia Co, Ltd. | 2012-05-08 |
| AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION (K103230) | Bestgen Biotech Corp. | 2012-04-24 |
| MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL (K120448) | Apex BioTechnology Corp. | 2012-04-06 |
| GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL (K113547) | Apex BioTechnology Corp. | 2012-03-28 |
| AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM (K103116) | Bestgen Biotech Corp. | 2012-03-13 |
| GAL-1A BLOOD GLUCOSE MONITORING SYSTEM (K113208) | Apex BioTechnology Corp. | 2012-01-26 |
| ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION (K103278) | I-Sens, Inc. | 2011-10-28 |
| GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM (K102316) | Broadmaster Biotech Corporation | 2011-10-07 |
| ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM (K111371) | ACON Laboratories, Inc. | 2011-10-06 |
| EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM (K111728) | Eps Bio Technology Corp. | 2011-09-16 |
| MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION (K101204) | Apex BioTechnology Corp. | 2011-08-31 |
| UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 (K103842) | Beckman Coulter, Inc. | 2011-04-27 |
| IVD-GE02 (K101947) | Sphere Medical , Ltd. | 2011-03-16 |
| I-STAT 1 WIRELESS ANALYZER (K103195) | Abbott Point of Care, Inc. | 2011-02-08 |
| DIATRON PICTUS 400 (K101741) | Diatron Group | 2011-01-25 |
| ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2 (K100525) | Seppim S.A.S. | 2010-12-15 |
| AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS (K102037) | Apex BioTechnology Corp. | 2010-08-13 |
| FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM (K100405) | Taidoc Technology Corporation | 2010-07-09 |
| FORA V20 BLOOD GLUCOSE MONITORING SYSTEM (K100406) | Taidoc Technology Corporation | 2010-05-11 |
| EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT (K100187) | Medica Corp. | 2010-05-05 |
| CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267 (K093506) | Taidoc Technology Corporation | 2010-04-01 |
| CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265 (K093941) | Taidoc Technology Corporation | 2010-03-26 |
| INTEGRATED LABORATORY AUTOMATION SOLUTION (K091975) | Integrated Laboratory Automation Solutions, Inc. | 2010-03-10 |
| DS-A BLOOD GLUCOSE MONITORING SYSTEM (K082965) | Alliance International Co., Ltd. | 2009-12-07 |
| ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM (K092104) | Arkray Factory USA, Inc. | 2009-11-24 |
| FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM; TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE (K091814) | Taidoc Technology Corporation | 2009-11-20 |
| ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS (K091102) | Arkray Factory USA, Inc. | 2009-10-23 |
| BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD (K090109) | Epocal, Inc. | 2009-06-24 |
| AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9 (K090043) | Apex BioTechnology Corp. | 2009-04-09 |
| U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM (K083570) | Taidoc Technology Corporation | 2009-03-11 |
| DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100 (K080636) | Hubdic Co., Ltd. | 2009-02-13 |
| FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254 (K082482) | Taidoc Technology Corporation | 2009-01-30 |
| FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245 (K083664) | Taidoc Technology Corporation | 2009-01-09 |
| GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 (K082417) | Arkray Factory USA, Inc. | 2008-10-21 |
| EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005 (K082121) | Eps Bio Technology Corp. | 2008-09-17 |
| FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM (K081714) | Taidoc Technology Corporation | 2008-07-25 |
| CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237 (K081609) | Taidoc Technology Corporation | 2008-07-02 |
| ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM (K073416) | Arkray Factory USA, Inc. | 2008-06-13 |
| GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1 (K073648) | Apex BioTechnology Corp. | 2008-04-10 |
| EASYRA CLINICAL CHEMISTRY ANALYZER (K070057) | Medica Corp. | 2007-08-30 |
| TRILOGY ANALYZER (K070704) | Drew Scientific, Inc. | 2007-07-13 |
| NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM (K070960) | Nova Biomedical Corp. | 2007-07-11 |
| GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM (K062799) | Apex BioTechnology Corp. | 2007-02-06 |
| NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM (K063821) | Nova Biomedical Corp. | 2007-01-24 |
| EUKARE (K062892) | Eumed Biotechnology Co., Ltd. | 2007-01-22 |
| EASYGLUCO, MODEL IGM-0002 G2 (K061431) | U. S. Diagnostics, Inc. | 2007-01-12 |
| SELFCHECK GLUCO (K061528) | Card Guard Scientific Survival , Ltd. | 2006-09-22 |
| EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014 (K061992) | Eps Bio Technology Corp. | 2006-09-19 |
| NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS (K060345) | Nova Biomedical Corp. | 2006-04-28 |
| ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001 (K053079) | Hypoguard USA, Inc. | 2006-03-28 |
| ACCUREX GLUCOSE TEST STRIP (K052207) | Incline Medical, LLC | 2006-03-09 |
| GEM PREMIER 3000 (K052121) | Instrumentation Laboratory CO | 2005-10-21 |
| Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM (K050182) | Biomedix, Inc. | 2005-08-09 |
| GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM (K051285) | Infopia Co, Ltd. | 2005-08-02 |
| ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM (K043197) | Lifescan, Inc. | 2005-05-20 |
| EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM (K043245) | Eps Bio Technology Corp. | 2005-04-29 |
| EASYGLUCO IGM-0002 G2 (K043512) | American Healthcare, Inc. | 2005-04-08 |
| ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100 (K041881) | Hypoguard USA, Inc. | 2005-03-25 |
| GLUCOSE OXIDASE, GLUCOSE (K040974) | Genchem, Inc. | 2004-12-27 |
| THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS (K041427) | Arkray, Inc. | 2004-11-24 |
| BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR (K041478) | Becton Dickinson | 2004-10-28 |
| ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE (K042015) | Bayer Healthcare, Diagnostics Division | 2004-09-29 |
| Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM (K033627) | Biomedix, Inc. | 2004-05-21 |