510(k) K201956 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Zeus IFA ANA HEp-2 Test System, Zeus dIFine
| Applicant | Zeus Scientific, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Apr 29, 2022 |
| Received | Jul 14, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201956
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.