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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K961610
Device Name R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)
Applicant
R&D Systems, Inc.
614 Mckinley Pl NE
Minneapolis,  MN  55413
Applicant Contact KENNETH T EDDS, PH.D.
Correspondent
R&D Systems, Inc.
614 Mckinley Pl NE
Minneapolis,  MN  55413
Correspondent Contact KENNETH T EDDS, PH.D.
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received04/25/1996
Decision Date 07/01/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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