510(k) K120889 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
AESKUSLIDES ANA HEP-2
| Applicant | Aesku Diagnostics, Pedricktown NJ, US |
| Decision | Substantially Equivalent, Oct 15, 2012 |
| Received | Mar 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120889
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.