510(k) K101644 ยท MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
QUANTA FLASH H-TTG IGG
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Mar 23, 2011 |
| Received | Jun 10, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101644
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.