510(k) K872845 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM
| Applicant | Bion Ent., Ltd., Park Ridge IL, US |
| Decision | Substantially Equivalent, Aug 17, 1987 |
| Received | Jul 20, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K872845
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.