EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W— 510(k) K110393

Name: FDA 510(k) clearance K110393
Creator: U.S. Food and Drug Administration
Published: 2011-03-04

Substantially Equivalent

Ekf-Diagnostic GmbH

FDA 510(k) clearance K110393 for EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W, Substantially Equivalent on 2011-03-04. Applicant: Ekf-Diagnostic GmbH. Device class: 2.

Clearance details

Applicant: Ekf-Diagnostic GmbH
Product code: Code GKR
Device class: Class 2
Regulation: 21 CFR 864.5620
Advisory panel: Hematology
Date received: 2011-02-11
Decision date: 2011-03-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Egale, WI, US

Download summary PDF View on FDA.gov ↗

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