510(k) K043433 ยท MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA
| Applicant | Hycor Biomedical , Ltd., Penicuik, Midlothian, GB |
| Decision | Substantially Equivalent, Mar 7, 2005 |
| Received | Dec 13, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043433
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.