510(k) K000751 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
RHIGENE MESACUP2 TEST- SSB
| Applicant | Rhigene, Inc., Des Plaines IL, US |
| Decision | Substantially Equivalent, May 9, 2000 |
| Received | Mar 8, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000751
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.