510(k) K031308 ยท DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760
| Applicant | Rhigene, Inc., Westminster CO, US |
| Decision | Substantially Equivalent, Sep 26, 2003 |
| Received | Apr 24, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031308
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.