510(k) K041174 ยท MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196
| Applicant | Sweden Diagnostics (Germany) GmbH, Freiburg, DE |
| Decision | Substantially Equivalent, Jul 19, 2004 |
| Received | May 5, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041174
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.