510(k) K022800 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM
| Applicant | Hyperion, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Nov 25, 2002 |
| Received | Aug 23, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022800
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.