510(k) K965133 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
ANCA COMBI DIAGNOSTIC TEST KIT
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, May 21, 1997 |
| Received | Dec 23, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965133
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.