510(k) K780104 ยท JMK Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
ULTRAZYME PLUS HBD
| Applicant | Harleco, Mchenry IL, US |
| Decision | Substantially Equivalent, Feb 13, 1978 |
| Received | Jan 20, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K780104
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.