510(k) K172745 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
ImmuGlo HEp-2 Elite IFA
| Applicant | Immco Diagnostics, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Jun 5, 2018 |
| Received | Sep 12, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172745
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.