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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 K200909
Device Name Hemo Control (optional Add Pack Hemo Control DM)
Applicant
Ekf-Diagnostic GmbH
Ebendorfer Chaussee 3
Barleben,  DE 39179
Applicant Contact Andrew J. Rutter
Correspondent
Ekf-Diagnostic GmbH
Ebendorfer Chaussee 3
Barleben,  DE 39179
Correspondent Contact Andrew J. Rutter
Regulation Number864.5620
Classification Product Code
GKR  
Subsequent Product Code
KHG  
Date Received04/06/2020
Decision Date 06/12/2020
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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