510(k) K030681 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
QUANTA PLEX ENA PROFILE 5
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 24, 2003 |
| Received | Mar 5, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030681
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.