510(k) K033528 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
MESACUP-2 TEST JO-1, MODEL 10756
| Applicant | Rhigene, Inc., Westminster CO, US |
| Decision | Substantially Equivalent, Dec 22, 2003 |
| Received | Nov 7, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033528
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.