CGL
- Product code
- CGL
- Device name
- Electrode, Ion Based, Enzymatic, Creatinine
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.1225
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 8
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261039 | 2026-06-26 | Abbott Point of Care, Inc. | i-STAT Crea cartridge with the i-STAT 1 System |
Official FDA classification page: CGL
Classification and pathway per current FDA publications. Data from openFDA (CC0).