CGA
- Product code
- CGA
- Device name
- Glucose Oxidase, Glucose
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.1345
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 401 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252488 | 2026-05-01 | Radiometer Medicals Aps | ABL90 FLEX PLUS System | |
| K210933 | 2024-09-30 | Ysi, Inc. | YSI 2900C Biochemistry Analyzer | |
| K220328 | 2024-07-26 | Medica Corporation | EasyStat 300 | FDA |
| K223179 | 2023-09-20 | Alere San Diego, Inc. | Cholestech LDX System | |
| K223755 | 2023-09-11 | Abbott Point of Care, Inc. | i-STAT G cartridge with the i-STAT 1 System |
Official FDA classification page: CGA
Classification and pathway per current FDA publications. Data from openFDA (CC0).