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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 BK220790
Tradename Blood Bank Control Systems
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Blood Bank Computer Systems, Inc.
7206 vandermark rd. e
bonney lake,  WA  98391
Regulation Number864.9165
Classification Product Code
MMH  
Date Received11/29/2022
Decision Date 02/17/2023
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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