K110393

Substantially Equivalent

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

Applicant: Ekf-Diagnostic GmbH
Product code: GKR
Advisory panel: Hematology
Date received: 2011-02-11
Decision date: 2011-03-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Egale, WI, US

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