510(k) K800852 ยท KRZ Calibrator For Hemoglobin And Hematocrit Measurement
HEMESPEC CHECK SET
| Applicant | Helena Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, May 2, 1980 |
| Received | Apr 15, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K800852
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.