510(k) K862319 ยท JMK Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
HBDH (OPTIMIZED) REAGENT
| Applicant | Sigma Chemical Co., St. Louis MO, US |
| Decision | Substantially Equivalent, Jul 7, 1986 |
| Received | Jun 18, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862319
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.