Ekf-Diagnostic GmbH

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K200909Hemo Control (optional Add Pack Hemo Control DM)June 12, 2020
K180509Quo-Test A1c SystemFebruary 16, 2019
K172173DiaSpect Tm, DiaSpect Tm CuvettesApril 6, 2018
K110393EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES March 4, 2011