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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 BK950056
Tradename Cobe Spectra LRD Leukoreduction (System Versions)
Device Name Automated Blood Cell Separators
Original Applicant
COBE Cardiovascular, Inc.
1201 oak street
lakewood,  CO  80215
Regulation Number864.9245
Classification Product Code
GKT  
Date Received10/10/1995
Decision Date 01/31/1996
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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