510(k) K011570 ยท MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jul 9, 2001 |
| Received | May 21, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011570
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.