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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 K101578
Device Name R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL
Applicant
R & D SYSTEMS, INC.
614 MCKINLEY PL., N.E.
MINNEAPOLIS,  MN  55413
Applicant Contact NANCY RING
Correspondent
R & D SYSTEMS, INC.
614 MCKINLEY PL., N.E.
MINNEAPOLIS,  MN  55413
Correspondent Contact NANCY RING
Regulation Number864.8625
Classification Product Code
JPK  
Date Received06/07/2010
Decision Date 04/28/2011
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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