510(k) K861855 ยท JKF Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge
HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET
| Applicant | Sterling Diagnostics, Inc., Sterling Heights MI, US |
| Decision | Substantially Equivalent, Jun 16, 1986 |
| Received | May 14, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861855
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.