510(k) K935828 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)
| Applicant | Hemagen Diagnostics, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Apr 20, 1994 |
| Received | Dec 7, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935828
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.