510(k) K915420 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
HEMAGEN ENA [JO-1] KIT (EIA METHOD)
| Applicant | Hemagen Diagnostics, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Apr 7, 1992 |
| Received | Dec 2, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915420
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.