JKF — Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge Class I
FDA Device Classification
Classification Details
- Product Code
- JKF
- Device Class
- Class I
- Regulation Number
- 862.1380
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K861855 | sterling diagnostics | HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET | June 16, 1986 |
| K834084 | sterling biochemical | HYDROXYBUTYRATE DEHYDROGENASE REAGENT | February 4, 1984 |