510(k) K955022 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
QUANTA LITE MPO
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Mar 19, 1996 |
| Received | Nov 2, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955022
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.