510(k) K883883 ยท LKJ Antinuclear Antibody, Antigen, Control
ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)
| Applicant | Immco Diagnostics, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Oct 27, 1988 |
| Received | Sep 13, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883883
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.