510(k) K912551 ยท DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
ANTI-ENDOMYSIAL ANTIBODY TEST
| Applicant | Immco Diagnostics, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Jun 9, 1993 |
| Received | Jun 11, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912551
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.