510(k) K897025 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM
| Applicant | Zeus Scientific, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Jan 2, 1990 |
| Received | Dec 19, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K897025
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.