510(k) K953452 ยท JMK Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
KETOREX C SANWA
| Applicant | Ihara Medics U.S., Inc., Valencia CA, US |
| Decision | Substantially Equivalent, May 2, 1996 |
| Received | Jul 18, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953452
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.