510(k) K822681 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
ANTI-NUCLEAR ANTIBODY TEST KIT (ANA)
| Applicant | Amico Lab, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Dec 13, 1982 |
| Received | Sep 3, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K822681
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.