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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name supplies, blood-bank
510(k) Number BK150289
Tradename Timestrip(R) Blood Temp 10 (BT10)
Device Name Supplies, Blood-Bank
Original Applicant
Timestrip UK Ltd.
22 friars street
sudbury
Suffolk,  CO102AA, 
Regulation Number864.9050
Classification Product Code
KSS  
Date Received07/02/2015
Decision Date 12/14/2015
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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