510(k) K954814 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY
| Applicant | Orgentec, Windham NH, US |
| Decision | Substantially Equivalent, Apr 18, 1996 |
| Received | Oct 19, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954814
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.