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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name container, empty, for collection & processing of blood & blood components
510(k) Number BK160027
Tradename Acrodose PL System
Device Name Container, Empty, For the Collection '& Processing of Blood/Blood Components
Original Applicant
Haemonetics Manufacturing Inc.
1630 industrial park street
covina,  CA  91722
Regulation Number864.9100
Classification Product Code
KSR  
Date Received03/18/2016
Decision Date 05/16/2016
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Special
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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