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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixture, Hematology Quality Control
510(k) Number K072268
Device Name HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S
Applicant
R & D SYSTEMS, INC.
614 MCKINLEY PL., N.E.
MINNEAPOLIS,  MN  55413
Applicant Contact NANCY C RING
Correspondent
R & D SYSTEMS, INC.
614 MCKINLEY PL., N.E.
MINNEAPOLIS,  MN  55413
Correspondent Contact NANCY C RING
Regulation Number864.8625
Classification Product Code
JPK  
Date Received08/15/2007
Decision Date 11/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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