510(k) K880653 ยท KQI Assay, Fetal Hemoglobin
HBF DILUENT
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Apr 21, 1988 |
| Received | Feb 17, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880653
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.