510(k) K920385 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
ANTI-ENA ANTIBODY TEST (SM)
| Applicant | Immco Diagnostics, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Mar 30, 1992 |
| Received | Jan 30, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920385
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.