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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
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