510(k) K955133 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
ORGENTEC ENASCREEN PIN IMMUNO ASSAY
| Applicant | Orgentec, Windham NH, US |
| Decision | Substantially Equivalent, Mar 20, 1996 |
| Received | Nov 9, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955133
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.