CJE
- Product code
- CJE
- Device name
- Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.1050
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 124 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251074 | 2025-12-19 | Truvian Health | Tru Liver Health Test Panel | |
| K240468 | 2024-10-16 | Abbott Laboratories Diagnostics Divisi… | Alkaline Phosphatase | FDA |
Official FDA classification page: CJE
Classification and pathway per current FDA publications. Data from openFDA (CC0).