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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 BK030006
Tradename Transwaag Disk 01
Device Name Device, Blood Mixing and Weighing
Original Applicant
Sarstedt, Inc.
1025 saint james church rd.
newton,  NC  20865
Regulation Number864.9195
Classification Product Code
KSQ  
Date Received02/04/2003
Decision Date 02/27/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Abbreviated
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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