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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, warming. blood and plasma
510(k) Number BK100051
Tradename Boekel Plasma Thawer, Model 301000
Device Name Device, Warming, Blood and Plasma
Original Applicant
Boekel Scientific, Inc
855 pennsylvania blvd.
feasterville,  PA  19053
Regulation Number864.9205
Classification Product Code
KZL  
Date Received08/23/2010
Decision Date 04/22/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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