510(k) K954831 ยท LKO Anti-Rnp Antibody, Antigen And Control
ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY
| Applicant | Orgentec, Windham NH, US |
| Decision | Substantially Equivalent, May 8, 1996 |
| Received | Oct 20, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954831
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.