510(k) K902139 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
HEMAGEN ENA [JO-I] KIT
| Applicant | Hemagen Diagnostics, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, May 18, 1990 |
| Received | May 9, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K902139
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.