ClearanceBrief
510(k) K110393 ยท GKR System, Hemoglobin, Automated

EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W

ApplicantEkf-Diagnostic GmbH, Egale WI, US
DecisionSubstantially Equivalent, Mar 4, 2011
ReceivedFeb 11, 2011
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K110393

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.