Ekf Diagnostic GmbH - FDA 510(k) Cleared Devices
Recent clearances: Hemo Control (optional Add Pack Hemo Control DM), Quo-Test A1c System, DiaSpect Tm, DiaSpect Tm Cuvettes
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ekf Diagnostic GmbH Hematology ✕
4 devices
Cleared
Jun 12, 2020
Hemo Control (optional Add Pack Hemo Control DM)
Hematology
67d
Cleared
Apr 06, 2018
DiaSpect Tm, DiaSpect Tm Cuvettes
Hematology
261d
Cleared
Mar 04, 2011
EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM
Hematology
21d
Cleared
Sep 24, 2003
EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM
Hematology
97d