510(k) K926114 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM
| Applicant | Tissue Culture Biotec, Inc., Bozeman MT, US |
| Decision | Substantially Equivalent, May 20, 1993 |
| Received | Dec 3, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K926114
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.