510(k) K200909 ยท GKR System, Hemoglobin, Automated
Hemo Control (optional Add Pack Hemo Control DM)
| Applicant | Ekf-Diagnostic GmbH, Barleben, DE |
| Decision | Substantially Equivalent, Jun 12, 2020 |
| Received | Apr 6, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200909
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.