510(k) K885224 ยท LKJ Antinuclear Antibody, Antigen, Control
ANA-5 AUTOANTIBODY PROFILE KIT
| Applicant | Autoimmunity Diagnostics Corp., Lake Villa IL, US |
| Decision | Substantially Equivalent, Apr 14, 1989 |
| Received | Dec 20, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K885224
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.