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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, detection, bacterial, for platelet transfusion products
510(k) Number BK180211
Tradenames BD BACTEC™ Platelet Aerobic/F Culture vials, BD BACTEC™ Platelet Anaerobic/F Culture Vials
Device Name System, Detection, Bacterial, Detection Systems for Platelet Transfusion Products
Original Applicant
Becton, Dickinson & Company
7 loveton circle, mc 694
sparks,  MD  21152 0999
Regulation Number866.2560
Classification Product Code
MZC  
Date Received05/10/2018
Decision Date 08/08/2018
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Immunology
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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