CGA — Glucose Oxidase, Glucose Class II
FDA Device Classification
Classification Details
- Product Code
- CGA
- Device Class
- Class II
- Regulation Number
- 862.1345
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K252488 | radiometer medicals aps | ABL90 FLEX PLUS System | May 1, 2026 |
| K210933 | ysi | YSI 2900C Biochemistry Analyzer | September 30, 2024 |
| K220328 | medica corporation | EasyStat 300 | July 26, 2024 |
| K223179 | alere san diego | Cholestech LDX System | September 20, 2023 |
| K223755 | abbott point of care | i-STAT G cartridge with the i-STAT 1 System | September 11, 2023 |
| K223710 | abbott point of care | i-STAT CG8+ cartridge with the i-STAT 1 System | July 28, 2023 |
| K223090 | instrumentation laboratory | GEM Premier ChemSTAT | January 27, 2023 |
| K203549 | nova biomedical corporation | Nova Primary Glucose Analyzer System | October 18, 2022 |
| K210958 | abbott point of care | i-STAT CHEM8+ cartridge with the i-STAT 1 System | August 13, 2021 |
| K200349 | nova biomedical corporation | Stat Profile Prime Plus Analyzer System | March 13, 2020 |
| K183678 | abbott point of care | i-STAT CHEM8+ cartridge with the i-STAT 1 System | February 7, 2020 |
| K190520 | ortho-clinical diagnostics | VITROS XT Chemistry Products GLU-Ca Slides | April 3, 2019 |
| K183546 | instrumentation laboratory | GEM Premier ChemSTAT | February 16, 2019 |
| K182781 | polymer technology systems, inc. d/b/a pts diagnostics | PTS Professional Chemistry Kit | December 21, 2018 |
| K180340 | nova biomedical corporation | Stat Profile Prime Plus Analyzer System | September 26, 2018 |
| K163433 | ortho clinical diagnostics | VITROS Chemistry Products GLU Slides | September 18, 2017 |
| K163271 | abbott point of care | i-Stat Alinity System with i-Stat Glucose test | April 10, 2017 |
| K162282 | polymer technology systems, inc. d/b/a pts diagnostics | CardioChek Plus Test System, CardioChek Home Test System | December 22, 2016 |
| K160402 | instrumentation laboratory | GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) | December 14, 2016 |
| K161818 | instrumentation laboratory | GEM Premier 3000 | September 14, 2016 |