CJJ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Diazo, Alt/Sgpt
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1030
- Medical specialty
- Clinical Chemistry
- Adverse events (MAUDE)
- 1994: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CALCIUM QVET (K943003) | Prisma Systems | 1994-12-09 |
| BIOTRACK ALT TEST CARTRIDGE (K895128) | Biotrack, Inc. | 1989-10-06 |
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