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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name separator, automated, blood cell, diagnostic
510(k) Number BK920023
Tradename Pall Autostop Leukocyte Removal Platelet Filter with Tubing
Device Name Automated Blood Cell Separator -Filtration
Original Applicant
Medsep Corporation
2200 northern boulevard
east hills,  NY  11548 1289
Regulation Number864.9245
Classification Product Code
GKT  
Date Received06/19/1992
Decision Date 10/26/1992
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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