510(k) K974166 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
WIELISA MPO ANCA TEST SYSTEM
| Applicant | Wieslab AB, Frederick MD, US |
| Decision | Substantially Equivalent, Feb 17, 1998 |
| Received | Nov 5, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974166
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.