510(k) K982121 ยท DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT
| Applicant | Trace Scientific , Ltd., Miami FL, US |
| Decision | Substantially Equivalent, Sep 17, 1998 |
| Received | Jun 16, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982121
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.