510(k) K061408 ยท MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT
| Applicant | Euroimmun Us, LLC, Boonton Township NJ, US |
| Decision | Substantially Equivalent, Oct 5, 2006 |
| Received | May 22, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061408
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.