Product code CGA
- Device name
- Glucose Oxidase, Glucose
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1345
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P990026S017 | GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2003-06-17 |
| P990026S016 | GLUCOWATCH G2 BIOGRAPHER | Animas Corp. | 2002-12-31 |
| P990026S015 | GLUCOWATCH G2 BIOGRAPHER | Animas Corp. | 2002-09-23 |
| P990026S008 | GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2002-08-26 |
| P990026S014 | GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2002-08-23 |
| P990026S013 | GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2002-07-25 |
| P990026S011 | GLUCOWATCH 2 BIOGRAPHER | Animas Corp. | 2002-03-21 |
| P990026S012 | CYGNUS GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2002-02-04 |
| P990026S010 | GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2001-11-30 |
| P990026S009 | GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2001-11-30 |
| P990026S007 | GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2001-10-25 |
| P990026S006 | GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2001-09-04 |
| P990026S005 | GLUCOWATCH(R) AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2001-08-28 |
| P990026S004 | GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2001-08-03 |
| P990026S002 | GLUCOWATCH (R) AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2001-05-22 |
| P990026S001 | GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. | 2001-05-03 |
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| K252488 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | 2026-05-01 |
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| K223755 | i-STAT G cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023-09-11 |
| K223710 | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023-07-28 |
| K223090 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2023-01-27 |
| K203549 | Nova Primary Glucose Analyzer System | Nova Biomedical Corporation | 2022-10-18 |
| K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2021-08-13 |
| K200349 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2020-03-13 |
| K183678 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020-02-07 |
| K190520 | VITROS XT Chemistry Products GLU-Ca Slides | Ortho-Clinical Diagnostics, Inc. | 2019-04-03 |
| K183546 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2019-02-16 |
| K182781 | PTS Professional Chemistry Kit | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2018-12-21 |
| K180340 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2018-09-26 |
| K163433 | VITROS Chemistry Products GLU Slides | Ortho Clinical Diagnostics | 2017-09-18 |
| K163271 | i-Stat Alinity System with i-Stat Glucose test | Abbott Point of Care, Inc. | 2017-04-10 |
| K162282 | CardioChek Plus Test System, CardioChek Home Test System | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2016-12-22 |
| K160402 | GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) | Instrumentation Laboratory CO | 2016-12-14 |
| K161818 | GEM Premier 3000 | Instrumentation Laboratory CO | 2016-09-14 |
| K153692 | Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer | Infrared Laboratory Systems, LLC (Dba Synermed) | 2016-06-24 |
| K151639 | ABL80 FLEX and ABL80 FLEX CO-OX | Sendx Medical, Inc. | 2015-12-07 |
| K142689 | GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2015-08-06 |
| K151530 | CardioChek Plus Test System | Polymer Technology Systems, Inc. | 2015-07-07 |
| K143750 | MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2015-05-07 |
| 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 PANEL... | Polymer Technology Systems, Inc. | 2014-10-02 |
| K142336 | GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System | Arkray Factory, Inc. | 2014-09-17 |
| K133584 | IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM | Eoshealth, Inc. | 2014-09-08 |
| K124021 | ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM | Arkray Factory, Inc. | 2014-06-30 |
| K131750 | AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM | Apex BioTechnology Corp. | 2014-03-06 |
Related GUDID Devices#
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|---|---|---|---|
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| 00015482502300 | Assure® Platinum | Arkray USA, Inc. | 2019-11-25 |
| 00015482512057 | GLUCOCARD® W Blood Glucose Test Strips | Arkray USA, Inc. | 2019-04-01 |
| 00859519002018 | BioTel Care® Test Strips | TELCARE, LLC | 2019-03-11 |
| 30015482542994 | GLUCOCARD® Shine XL Blood Glucose Monitoring System | Arkray USA, Inc. | 2017-09-12 |
| 00015482540104 | GLUCOCARD® Shine BLOOD GLUCOSE TEST STRIPS | Arkray USA, Inc. | 2017-04-19 |
| 00015482540500 | GLUCOCARD® Shine BLOOD GLUCOSE TEST STRIPS | Arkray USA, Inc. | 2017-04-19 |
| 00015482530501 | ASSURE® PRISM MULTI BLOOD GLUCOSE TEST STRIPS | Arkray USA, Inc. | 2017-02-17 |
| 00015482500504 | Assure® Platinum BLOOD GLUCOSE TEST STRIPS | Arkray USA, Inc. | 2017-02-12 |
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| 30015482571888 | GLUCOCARD® Expression™ Blood Glucose Monitoring System | Arkray USA, Inc. | 2016-09-23 |
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| 00015482740504 | GLUCOCARD® 01 BLOOD GLUCOSE TEST STRIPS | Arkray USA, Inc. | 2016-09-23 |
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| 00015482572051 | GLUCOCARD® EXPRESSION Blood Glucose Test Strips | Arkray USA, Inc. | 2016-09-23 |
| 00015482570057 | GLUCOCARD® EXPRESSION Blood Glucose Test Strips | Arkray USA, Inc. | 2016-09-23 |
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| 00015482183103 | SPOTCHEM™ EZ Analyzer | Arkray USA, Inc. | 2016-09-23 |