510(k) K860428 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
SM-RNP AUTOANTIBODY TEST SYSTEM
| Applicant | Immuno Concepts, Inc., Sacramento CA, US |
| Decision | Substantially Equivalent, May 15, 1986 |
| Received | Feb 4, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860428
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.