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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name c-reactive protein, antigen, antiserum, and control
510(k) Number K884101
Device Name DU PONT DIMENSION C-REACTIVE PROTEIN CALIBRATOR
Applicant
E.I. DUPONT DE NEMOURS & CO., INC.
medical products department
barley mill plaza, p22-1170
wilmington,  DE  19898
Applicant Contact richard m vaught
Correspondent
E.I. DUPONT DE NEMOURS & CO., INC.
medical products department
barley mill plaza, p22-1170
wilmington,  DE  19898
Correspondent Contact richard m vaught
Regulation Number866.5270
Classification Product Code
DCK  
Date Received08/17/1988
Decision Date 10/19/1988
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
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