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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 K840302
Device Name PLT - 4 PLATELET
Applicant
R & D SYSTEMS, INC.
803 N. Front St. Suite 3
mchenry,  IL  60050
Correspondent
R & D SYSTEMS, INC.
803 N. Front St. Suite 3
mchenry,  IL  60050
Regulation Number864.8625
Classification Product Code
JPK  
Date Received01/24/1984
Decision Date 03/12/1984
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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