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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 K072096
Device Name CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04
Applicant
R&D Systems, Inc.
614 Mckinley Pl NE
Minneapolis,  MN  55413
Applicant Contact NANCY C RING
Correspondent
R&D Systems, Inc.
614 Mckinley Pl NE
Minneapolis,  MN  55413
Correspondent Contact NANCY C RING
Regulation Number864.8625
Classification Product Code
JPK  
Date Received07/31/2007
Decision Date 08/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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