510(k) K972145 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
| Applicant | Immuno Concepts, Inc., Sacramento CA, US |
| Decision | Substantially Equivalent, Feb 24, 1998 |
| Received | Jun 6, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972145
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.