510(k) K040200 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
MESACUP-2 TEST CENP-B
| Applicant | Rhigene, Inc., Des Plaines IL, US |
| Decision | Substantially Equivalent, Mar 4, 2004 |
| Received | Jan 29, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040200
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.