510(k) K821877 ยท JMK Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
ULTRAZYME PLUS HBD
| Applicant | Harleco Diagnostics, Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 14, 1982 |
| Received | Jun 25, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821877
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.