510(k) K862313 ยท LKJ Antinuclear Antibody, Antigen, Control
KALLESTAD SM/RNP TEST REAGENT
| Applicant | Kallestad Laboratories, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Aug 6, 1986 |
| Received | Jun 18, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862313
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.