510(k) K131791 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
IFA 40: HEP-20-10
| Applicant | Euroimmun US, Morris Plains NJ, US |
| Decision | Substantially Equivalent, Feb 26, 2014 |
| Received | Jun 18, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131791
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.