FDA Product Code
FDA Product Code CGA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1345
510(k) Clearances — 401 records · page 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252488 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | 2026-05-01 | Traditional | PDF ↗ |
| K210933 | YSI 2900C Biochemistry Analyzer | Ysi, Inc. | 2024-09-30 | Traditional | PDF ↗ |
| K220328 | EasyStat 300 | Medica Corporation | 2024-07-26 | Traditional | PDF ↗ |
| K223179 | Cholestech LDX System | Alere San Diego, Inc. | 2023-09-20 | Dual Track | PDF ↗ |
| K223755 | i-STAT G cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023-09-11 | Traditional | PDF ↗ |
| K223710 | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023-07-28 | Traditional | PDF ↗ |
| K223090 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2023-01-27 | Special | PDF ↗ |
| K203549 | Nova Primary Glucose Analyzer System | Nova Biomedical Corporation | 2022-10-18 | Traditional | PDF ↗ |
| K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2021-08-13 | Traditional | PDF ↗ |
| K200349 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2020-03-13 | Traditional | PDF ↗ |
| K183678 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020-02-07 | Traditional | PDF ↗ |
| K190520 | VITROS XT Chemistry Products GLU-Ca Slides | Ortho-Clinical Diagnostics, Inc. | 2019-04-03 | Traditional | PDF ↗ |
| K183546 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2019-02-16 | Traditional | PDF ↗ |
| K182781 | PTS Professional Chemistry Kit | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2018-12-21 | Traditional | PDF ↗ |
| K180340 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2018-09-26 | Traditional | PDF ↗ |
| K163433 | VITROS Chemistry Products GLU Slides | Ortho Clinical Diagnostics | 2017-09-18 | Traditional | PDF ↗ |
| K163271 | i-Stat Alinity System with i-Stat Glucose test | Abbott Point of Care, Inc. | 2017-04-10 | Traditional | PDF ↗ |
| K162282 | CardioChek Plus Test System, CardioChek Home Test System | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2016-12-22 | Special | PDF ↗ |
| K160402 | GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) | Instrumentation Laboratory CO | 2016-12-14 | Traditional | PDF ↗ |
| K161818 | GEM Premier 3000 | Instrumentation Laboratory CO | 2016-09-14 | Special | PDF ↗ |
| K153692 | Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer | Infrared Laboratory Systems, LLC (Dba Synermed) | 2016-06-24 | Traditional | PDF ↗ |
| K151639 | ABL80 FLEX and ABL80 FLEX CO-OX | Sendx Medical, Inc. | 2015-12-07 | Traditional | PDF ↗ |
| K142689 | GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2015-08-06 | Special | PDF ↗ |
| K151530 | CardioChek Plus Test System | Polymer Technology Systems, Inc. | 2015-07-07 | Traditional | PDF ↗ |
| K143750 | MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2015-05-07 | Special | PDF ↗ |
| K142302 | 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 | Polymer Technology Systems, Inc. | 2014-10-02 | Traditional | PDF ↗ |
| K142336 | GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System | Arkray Factory, Inc. | 2014-09-17 | Special | PDF ↗ |
| K133584 | IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM | Eoshealth, Inc. | 2014-09-08 | Traditional | PDF ↗ |
| K124021 | ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM | Arkray Factory, Inc. | 2014-06-30 | Traditional | PDF ↗ |
| K131750 | AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM | Apex BioTechnology Corp. | 2014-03-06 | Traditional | PDF ↗ |
| K120615 | ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE | Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen | 2013-05-15 | Traditional | PDF ↗ |
| K113636 | BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE) | Philosys Co., Ltd. | 2013-03-08 | Traditional | PDF ↗ |
| K121706 | FORA V10 BLOOD GLUCOSE MONITORING SYSTEM | Foracare, Inc. | 2013-01-14 | Traditional | PDF ↗ |
| K122110 | ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM | ACON Laboratories, Inc. | 2012-11-21 | Special | PDF ↗ |
| K121654 | AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION | I-Sens, Inc. | 2012-09-05 | Special | PDF ↗ |
| K120921 | CLEVER CHOICE | Simple Diagnostics, Inc. | 2012-08-21 | Traditional | PDF ↗ |
| K120759 | CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION | I-Sens, Inc. | 2012-06-05 | Special | PDF ↗ |
| K113670 | ELEMENT BLOOD GLUCOSE MONITORING SYSTEM | Infopia Co, Ltd. | 2012-05-08 | Special | PDF ↗ |
| K103230 | AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION | Bestgen Biotech Corp. | 2012-04-24 | Traditional | PDF ↗ |
| K120448 | MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL | Apex BioTechnology Corp. | 2012-04-06 | Special | PDF ↗ |
| K113547 | GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL | Apex BioTechnology Corp. | 2012-03-28 | Traditional | PDF ↗ |
| K103116 | AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM | Bestgen Biotech Corp. | 2012-03-13 | Special | PDF ↗ |
| K113208 | GAL-1A BLOOD GLUCOSE MONITORING SYSTEM | Apex BioTechnology Corp. | 2012-01-26 | Special | PDF ↗ |
| K103278 | ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION | I-Sens, Inc. | 2011-10-28 | Special | PDF ↗ |
| K102316 | GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM | Broadmaster Biotech Corporation | 2011-10-07 | Traditional | PDF ↗ |
| K111371 | ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM | ACON Laboratories, Inc. | 2011-10-06 | Traditional | PDF ↗ |
| K111728 | EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | Eps Bio Technology Corp. | 2011-09-16 | Special | PDF ↗ |
| K101204 | MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION | Apex BioTechnology Corp. | 2011-08-31 | Traditional | PDF ↗ |
| K103842 | UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 | Beckman Coulter, Inc. | 2011-04-27 | Traditional | PDF ↗ |
| K101947 | IVD-GE02 | Sphere Medical , Ltd. | 2011-03-16 | Traditional | PDF ↗ |
| K103195 | I-STAT 1 WIRELESS ANALYZER | Abbott Point of Care, Inc. | 2011-02-08 | Traditional | PDF ↗ |
| K101741 | DIATRON PICTUS 400 | Diatron Group | 2011-01-25 | Traditional | PDF ↗ |
| K100525 | ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2 | Seppim S.A.S. | 2010-12-15 | Traditional | PDF ↗ |
| K102037 | AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS | Apex BioTechnology Corp. | 2010-08-13 | Special | PDF ↗ |
| K100405 | FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | 2010-07-09 | Special | PDF ↗ |
| K100406 | FORA V20 BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | 2010-05-11 | Special | PDF ↗ |
| K100187 | EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT | Medica Corp. | 2010-05-05 | Traditional | PDF ↗ |
| K093506 | CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267 | Taidoc Technology Corporation | 2010-04-01 | Special | PDF ↗ |
| K093941 | CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265 | Taidoc Technology Corporation | 2010-03-26 | Special | PDF ↗ |
| K091975 | INTEGRATED LABORATORY AUTOMATION SOLUTION | Integrated Laboratory Automation Solutions, Inc. | 2010-03-10 | Traditional | PDF ↗ |
| K082965 | DS-A BLOOD GLUCOSE MONITORING SYSTEM | Alliance International Co., Ltd. | 2009-12-07 | Traditional | PDF ↗ |
| K092104 | ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM | Arkray Factory USA, Inc. | 2009-11-24 | Traditional | PDF ↗ |
| K091814 | FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM; TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE | Taidoc Technology Corporation | 2009-11-20 | Traditional | PDF ↗ |
| K091102 | ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS | Arkray Factory USA, Inc. | 2009-10-23 | Traditional | PDF ↗ |
| K090109 | BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD | Epocal, Inc. | 2009-06-24 | Traditional | PDF ↗ |
| K090043 | AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9 | Apex BioTechnology Corp. | 2009-04-09 | Special | PDF ↗ |
| K083570 | U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | 2009-03-11 | Special | PDF ↗ |
| K080636 | DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100 | Hubdic Co., Ltd. | 2009-02-13 | Traditional | PDF ↗ |
| K082482 | FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254 | Taidoc Technology Corporation | 2009-01-30 | Special | PDF ↗ |
| K083664 | FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245 | Taidoc Technology Corporation | 2009-01-09 | Special | PDF ↗ |
| K082417 | GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 | Arkray Factory USA, Inc. | 2008-10-21 | Special | PDF ↗ |
| K082121 | EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005 | Eps Bio Technology Corp. | 2008-09-17 | Special | PDF ↗ |
| K081714 | FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM | Taidoc Technology Corporation | 2008-07-25 | Special | PDF ↗ |
| K081609 | CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237 | Taidoc Technology Corporation | 2008-07-02 | Special | PDF ↗ |
| K073416 | ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM | Arkray Factory USA, Inc. | 2008-06-13 | Traditional | PDF ↗ |
| K073648 | GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1 | Apex BioTechnology Corp. | 2008-04-10 | Traditional | PDF ↗ |
| K070057 | EASYRA CLINICAL CHEMISTRY ANALYZER | Medica Corp. | 2007-08-30 | Traditional | PDF ↗ |
| K070704 | TRILOGY ANALYZER | Drew Scientific, Inc. | 2007-07-13 | Traditional | PDF ↗ |
| K070960 | NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM | Nova Biomedical Corp. | 2007-07-11 | Special | PDF ↗ |
| K062799 | GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM | Apex BioTechnology Corp. | 2007-02-06 | Traditional | PDF ↗ |
| K063821 | NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM | Nova Biomedical Corp. | 2007-01-24 | Traditional | PDF ↗ |
| K062892 | EUKARE | Eumed Biotechnology Co., Ltd. | 2007-01-22 | Traditional | PDF ↗ |
| K061431 | EASYGLUCO, MODEL IGM-0002 G2 | U. S. Diagnostics, Inc. | 2007-01-12 | Traditional | PDF ↗ |
| K061528 | SELFCHECK GLUCO | Card Guard Scientific Survival , Ltd. | 2006-09-22 | Traditional | PDF ↗ |
| K061992 | EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014 | Eps Bio Technology Corp. | 2006-09-19 | Special | PDF ↗ |
| K060345 | NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS | Nova Biomedical Corp. | 2006-04-28 | Traditional | PDF ↗ |
| K053079 | ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001 | Hypoguard USA, Inc. | 2006-03-28 | Traditional | PDF ↗ |
| K052207 | ACCUREX GLUCOSE TEST STRIP | Incline Medical, LLC | 2006-03-09 | Traditional | PDF ↗ |
| K052121 | GEM PREMIER 3000 | Instrumentation Laboratory CO | 2005-10-21 | Special | PDF ↗ |
| K050182 | Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM | Biomedix, Inc. | 2005-08-09 | Traditional | PDF ↗ |
| K051285 | GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM | Infopia Co, Ltd. | 2005-08-02 | Traditional | PDF ↗ |
| K043197 | ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM | Lifescan, Inc. | 2005-05-20 | Traditional | PDF ↗ |
| K043245 | EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM | Eps Bio Technology Corp. | 2005-04-29 | Traditional | PDF ↗ |
| K043512 | EASYGLUCO IGM-0002 G2 | American Healthcare, Inc. | 2005-04-08 | Traditional | PDF ↗ |
| K041881 | ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100 | Hypoguard USA, Inc. | 2005-03-25 | Traditional | PDF ↗ |
| K040974 | GLUCOSE OXIDASE, GLUCOSE | Genchem, Inc. | 2004-12-27 | Traditional | PDF ↗ |
| K041427 | THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS | Arkray, Inc. | 2004-11-24 | Traditional | PDF ↗ |
| K041478 | BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR | Becton Dickinson | 2004-10-28 | Traditional | PDF ↗ |
| K042015 | ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE | Bayer Healthcare, Diagnostics Division | 2004-09-29 | Traditional | PDF ↗ |
| K033627 | Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM | Biomedix, Inc. | 2004-05-21 | Traditional | PDF ↗ |
Product code CGA · Class II · Clinical Chemistry. Data: openFDA.