510(k) K974463 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
IMMUNO CONCEPTS ANCA TEST SYSTEM
| Applicant | Immuno Concepts, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Feb 9, 1998 |
| Received | Nov 26, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974463
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.