JLP
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Spectrophotometric Method, Pregnanediol
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1605
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| OVEIA (TM) DUAL ANALYTE (K872843) | Boots-Celltech Diagnostics, Inc. | 1988-02-02 |
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