510(k) K945607 ยท DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
VARELISA M2 ANTIBODIES
| Applicant | Elias U.S.A., Inc., Osceola WI, US |
| Decision | Substantially Equivalent, Jan 24, 1995 |
| Received | Nov 15, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945607
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.