510(k) K812226 ยท KQI Assay, Fetal Hemoglobin
HELENA HBF QUIPLATE CONTROL
| Applicant | Helena Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 1, 1981 |
| Received | Aug 10, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812226
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.