510(k) K981209 ยท MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Oct 22, 1998 |
| Received | Apr 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981209
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.