510(k) K780899 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
FLUORESCENT ANTI-NATIVE DNA TEST
| Applicant | Kallestad Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 7, 1978 |
| Received | Jun 2, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K780899
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.