510(k) K880896 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
NOVA GEL(TM) SS-A/SS-B
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Mar 25, 1988 |
| Received | Mar 2, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880896
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.