510(k) K041102 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA
| Applicant | Immco Diagnostics, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Oct 26, 2004 |
| Received | Apr 27, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041102
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.