EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM— 510(k) K031898

Name: FDA 510(k) clearance K031898
Creator: U.S. Food and Drug Administration
Published: 2003-09-24

Substantially Equivalent

Ekf Diagnostic GmbH

FDA 510(k) clearance K031898 for EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM, Substantially Equivalent on 2003-09-24. 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: 2003-06-19
Decision date: 2003-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Egale, WI, US

Download summary PDF View on FDA.gov ↗

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