FDA Product Code
FDA Product Code JKF — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1380
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K861855 | HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET | Sterling Diagnostics, Inc. | 1986-06-16 | Traditional | PDF ↗ |
| K834084 | HYDROXYBUTYRATE DEHYDROGENASE REAGENT | Sterling Biochemical, Inc. | 1984-02-04 | Traditional | PDF ↗ |
Product code JKF · Class I · Clinical Chemistry. Data: openFDA.