510(k) K983860 ยท JMK Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
MTM BIOSCANNER K TEST STRIPS, CAT # BSA610
| Applicant | Polymer Technology Systems, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 27, 1999 |
| Received | Nov 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983860
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.