The following data is part of a premarket notification filed by Sterling Biochemical, Inc. with the FDA for Hydroxybutyrate Dehydrogenase Reagent.
| Device ID | K834084 |
| 510k Number | K834084 |
| Device Name: | HYDROXYBUTYRATE DEHYDROGENASE REAGENT |
| Classification | Dinitrophenyl Hydrazone Measurement (colorimetric), Hydroxybutyric Dehydroge |
| Applicant | STERLING BIOCHEMICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JKF |
| CFR Regulation Number | 862.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-28 |
| Decision Date | 1984-02-04 |