510(k) K864668 ยท LKJ Antinuclear Antibody, Antigen, Control
ANA TEST KIT
| Applicant | Val Tech Diagnostics, Inc., Pittsburgh PA, US |
| Decision | Substantially Equivalent, Mar 12, 1987 |
| Received | Dec 2, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864668
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.