510(k) K791143 ยท KQI Assay, Fetal Hemoglobin
SICKLE-CELL F TEST
| Applicant | Isolab, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Jul 17, 1979 |
| Received | Jun 18, 1979 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K791143
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.