510(k) K031450 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
QUANTA PLEX ENA PROFILE 6
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 25, 2003 |
| Received | May 7, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031450
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.