The following data is part of a premarket notification filed by Sterling Diagnostics, Inc. with the FDA for Hydroxybutyrate Dehydrogenase (hbd) Reagent Set.
| Device ID | K861855 |
| 510k Number | K861855 |
| Device Name: | HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET |
| Classification | Dinitrophenyl Hydrazone Measurement (colorimetric), Hydroxybutyric Dehydroge |
| Applicant | STERLING DIAGNOSTICS, INC. 34210 DEQUINDRE RD. Sterling Heights, MI 48077 |
| Contact | David L Callender |
| Correspondent | David L Callender STERLING DIAGNOSTICS, INC. 34210 DEQUINDRE RD. Sterling Heights, MI 48077 |
| Product Code | JKF |
| CFR Regulation Number | 862.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-14 |
| Decision Date | 1986-06-16 |