510(k) K030238 ยท DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Mar 24, 2003 |
| Received | Jan 23, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030238
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.