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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, blood mixing and blood weighing
510(k) Number BK950042
Tradename Genesis Blood Collection Mixer
Device Name Device, Blood Mixing and Weighing
Original Applicant
National Hospital Specialties
104 johnson avenue
hackensack,  NJ  07601
Regulation Number864.9195
Classification Product Code
KSQ  
Date Received06/29/1995
Decision Date 09/19/1995
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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