510(k) K983924 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO
| Applicant | Immuno Concepts, Inc., Sacramento CA, US |
| Decision | Substantially Equivalent, Dec 18, 1998 |
| Received | Nov 4, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983924
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.