510(k) K950414 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
HEMAGEN ENA SM/RMP KIT (EIA METHOD)
| Applicant | Hemagen Diagnostics, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Mar 29, 1995 |
| Received | Jan 31, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950414
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.