510(k) K803016 ยท GKR System, Hemoglobin, Automated
HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.
| Applicant | Helena Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, Dec 30, 1980 |
| Received | Nov 28, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K803016
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.