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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 separator, automated, blood cell, diagnostic
510(k) Number BK830015
Tradenames Dideco BT 125, Dideco BT 225, Dideco BT 375, Dideco BT 691
Device Name Automated Blood Cell Separator -Filtration
Original Applicant
Cryosan Inc.
850 providence highway
dedham,  MA  02026
Regulation Number864.9245
Classification Product Code
GKT  
Date Received09/29/1983
Decision Date 10/31/1983
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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