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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name centrifuge, blood-bank for in vitro diagnostic use
510(k) Number BK910022
Tradenames Du Pont Sorvall RC 3B Plus, Du Pont Sorvall RC 3C Plus Centrifuge
Device Name Centrifuge, Blood Bank for in vitro Diagnostic Use
Original Applicant
E.I. duPont de Nemours & Company
medical products department
wilmington,  DE  19898
Regulation Number864.9275
Classification Product Code
KSO  
Date Received09/05/1991
Decision Date 01/21/1992
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 Yes
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