510(k) K961340 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
NOVA LITE ANCA
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jul 10, 1996 |
| Received | Mar 25, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961340
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.