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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 K904464
Device Name CBC-LASER(R) HEMATOLOGY CONTROL/MULTIPLE-MODIFIED
Original Applicant
R & D SYSTEMS, INC.
614 mckinley pl., n.e.
minneapolis,  MN  55413
Original Contact karen viskochil
Regulation Number864.8625
Classification Product Code
JPK  
Date Received10/01/1990
Decision Date 10/23/1990
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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