510(k) K962276 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
HEMAGEN ENA DSDNA KIT (EIA METHOD)
| Applicant | Hemagen Diagnostics, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Dec 5, 1996 |
| Received | Jun 13, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962276
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.