510(k) K852840 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST
| Applicant | Modern Diagnostics, Inc., Sacramento CA, US |
| Decision | Substantially Equivalent, Aug 1, 1985 |
| Received | Jul 5, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K852840
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.