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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name control, hematocrit
510(k) Number K121467
Model 190.000.005, 195.002.010, 195.003.010, 195.004.010
Device Name EUROTROL HEMATOCRIT CONTROL
Original Applicant
EUROTROL B.V.
keplerlaan 20
ede,  NL 6716 bs
Original Contact paul b.p. kooijmans
Regulation Number864.8625
Classification Product Code
GLK  
Date Received05/17/2012
Decision Date 05/10/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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