510(k) K993034 ยท MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD
| Applicant | Medica, Inc., Encinitas CA, US |
| Decision | Substantially Equivalent, Nov 1, 1999 |
| Received | Sep 9, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993034
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.