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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Hemoglobin, Automated
510(k) Number K110393
Device Name EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W
Applicant
Ekf-Diagnostic GmbH
S65w35739 Piper Rd.
Egale,  WI  53119
Applicant Contact STEPHEN GORSKI
Correspondent
Ekf-Diagnostic GmbH
S65w35739 Piper Rd.
Egale,  WI  53119
Correspondent Contact STEPHEN GORSKI
Regulation Number864.5620
Classification Product Code
GKR  
Subsequent Product Code
KHG  
Date Received02/11/2011
Decision Date 03/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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