510(k) K981865 ยท JMK Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
MTM BIOSCANNER K TEST STRIPS
| Applicant | Polymer Technology Systems, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 26, 1999 |
| Received | May 28, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981865
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.