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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 K850755
Device Name CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL
Applicant
R&D Systems, Inc.
614 Mckinley Pl. NE
Minneapolis,  MN  55413
Applicant Contact DALE A CHRISTENSEN
Correspondent
R&D Systems, Inc.
614 Mckinley Pl. NE
Minneapolis,  MN  55413
Correspondent Contact DALE A CHRISTENSEN
Regulation Number864.8625
Classification Product Code
JPK  
Date Received02/25/1985
Decision Date 05/13/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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