510(k) K993612 ยท MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Dec 21, 1999 |
| Received | Oct 25, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993612
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.