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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cord blood processing system and storage container
510(k) Number BK120061
Tradename SynGenX-1000
Device Name Cord blood processing system and storage container
Original Applicant
SynGen, Inc
2125 19th street, suite 120
sacramento,  CA  95818
Regulation Number864.9900
Classification Product Code
OAO  
Date Received10/16/2012
Decision Date 07/12/2013
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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