ClearanceBrief
510(k) K172173 ยท GKR System, Hemoglobin, Automated

DiaSpect Tm, DiaSpect Tm Cuvettes

ApplicantEkf-Diagnostic GmbH, Barleben, DE
DecisionSubstantially Equivalent, Apr 6, 2018
ReceivedJul 19, 2017
TypeTraditional
FDA recordOpen 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.