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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name blood establishment computer software and accessories
510(k) Number BK210593
Tradename BTrac
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
BIQ-Health Solutions, Lda
rua ferreira de castro, 20c
barcarena,  Lisbon,  2730-081,  PORTUGAL
Regulation Number864.9165
Classification Product Code
MMH  
Date Received05/26/2021
Decision Date 08/13/2021
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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