510(k) K935416 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
RO EIA TEST KIT
| Applicant | David A. Fuccillo, Ph.D., Washington, D.C. DC, US |
| Decision | Substantially Equivalent, May 2, 1994 |
| Received | Nov 9, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935416
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.