FDA 510(k) Applications Submitted by EKF-DIAGNOSTIC GMBH

FDA 510(k) Number Submission Date Device Name Applicant
K200909 04/06/2020 Hemo Control (optional Add Pack Hemo Control DM) EKF-diagnostic GmbH
K180509 02/27/2018 Quo-Test A1c System EKF-diagnostic GmbH
K172173 07/19/2017 DiaSpect Tm, DiaSpect Tm Cuvettes EKF-diagnostic GmbH
K110393 02/11/2011 EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W EKF-DIAGNOSTIC GMBH


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