510(k) K973869 ยท CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt
TRACE REAGENT LINE FOR THE COBAS MIRA
| Applicant | Trace America, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Jan 7, 1998 |
| Received | Sep 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973869
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.