510(k) K943585 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
ANTI-HISTONE ANIBODY TEST
| Applicant | Immco Diagnostics, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Jan 20, 1995 |
| Received | Jul 22, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943585
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.