510(k) K862710 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
KALLESTAD SSA/SSB ENA TEST REAGENTS
| Applicant | Kallestad Laboratories, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Jul 29, 1986 |
| Received | Jul 16, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862710
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.