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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 BK070004
Tradename Pall eBDS
Device Name System, Detection, Bacterial, Detection Systems for Platelet Transfusion Products
Original Applicant
Haemonetics Manufacturing Inc.
400 wood road
braintree,  MA  02184
Regulation Number866.2560
Classification Product Code
MZC  
Date Received02/07/2007
Decision Date 06/26/2007
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 Yes
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