510(k) K181751 · GKR System, Hemoglobin, Automated
HemoCue Hb 801 System
| Applicant | Hemocue AB, Ängelholm, SE |
| Decision | Substantially Equivalent, Feb 1, 2019 |
| Received | Jul 2, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181751
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.