CGA — Glucose Oxidase, Glucose Class II
FDA product code CGA covers "Glucose Oxidase, Glucose", a Class II medical device regulated under 21 CFR 862.1345. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |