510(k) K013213 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
HYPERION VISIQUANT ANA TEST KIT
| Applicant | Hyperion, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Jun 4, 2002 |
| Received | Sep 26, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013213
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.