JKF
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1380
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET (K861855) | Sterling Diagnostics, Inc. | 1986-06-16 |
| HYDROXYBUTYRATE DEHYDROGENASE REAGENT (K834084) | Sterling Biochemical, Inc. | 1984-02-04 |
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