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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name control, hemoglobin
510(k) Number K182744
Device Name HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High
Applicant
EUROTROL B.V.
Keplerlaan 20
Ede,  NL 6716BS
Applicant Contact Mylene de Boer
Correspondent
EUROTROL B.V.
Keplerlaan 20
Ede,  NL 6716BS
Correspondent Contact Mylene de Boer
Regulation Number864.8625
Classification Product Code
GGM  
Date Received09/28/2018
Decision Date 02/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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