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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name set, transfer (blood/plasma)
510(k) Number BK950018
Tradename TOTAL CONTAINMENT DEVICE (TCD)
Device Name Set, Transfer (Blood/Plasma)
Original Applicant
GenesisBPS, LLC
65 commerce way
hackensack,  NJ  07601
Regulation Number864.9875
Classification Product Code
KSB  
Date Received02/27/1995
Decision Date 11/14/1995
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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