510(k) K040160 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
QUANTA PLEX SLE PROFILE 8
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Mar 8, 2004 |
| Received | Jan 23, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040160
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.