510(k) K050715 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
QUANTA PLEX ANCA PROFILE
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, May 12, 2005 |
| Received | Mar 18, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050715
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.