510(k) K964446 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
MYELOPEROXIDASE ELISA TEST SYSTEM
| Applicant | Zeus Scientific, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Apr 10, 1997 |
| Received | Nov 6, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964446
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.