510(k) K042680 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
RHIGENE HEP-ANA TEST SYSTEM
| Applicant | Corgenix, Inc., Des Plaines IL, US |
| Decision | Substantially Equivalent, Nov 19, 2004 |
| Received | Sep 29, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042680
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.