510(k) K895339 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST
| Applicant | Immco Diagnostics, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Oct 4, 1989 |
| Received | Aug 31, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895339
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.