510(k) K172173 ยท GKR System, Hemoglobin, Automated
DiaSpect Tm, DiaSpect Tm Cuvettes
| Applicant | Ekf-Diagnostic GmbH, Barleben, DE |
| Decision | Substantially Equivalent, Apr 6, 2018 |
| Received | Jul 19, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172173
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.