510(k) K980028 ยท CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt
ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
| Applicant | Trace America, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Feb 2, 1998 |
| Received | Jan 5, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980028
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.