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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name separator, automated, blood cell, diagnostic
510(k) Number BK870022
Tradename COBE Spectra Blood Component Separator
Device Name Automated Blood Cell Separator -Filtration
Original Applicant
Cobe Laboratories, Inc.
1185 oak street
lakewood,  CO  80215
Regulation Number864.9245
Classification Product Code
GKT  
Date Received08/25/1987
Decision Date 06/20/1988
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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