510(k) K981029 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Jul 20, 1998 |
| Received | Mar 19, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981029
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.