510(k) K915282 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
HEMAGEN ENA SCL-70 KIT (EIA METHOD)
| Applicant | Hemagen Diagnostics, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Feb 12, 1992 |
| Received | Nov 25, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915282
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.