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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 K945280
Device Name DUPONT DIMENSION C-REACTIVE PROTEIN METHOD
Applicant
Dupont Medical Products
Bmp 22/1168
Wilmington,  DE  19880
Applicant Contact CATHY P CRAFT
Correspondent
Dupont Medical Products
Bmp 22/1168
Wilmington,  DE  19880
Correspondent Contact CATHY P CRAFT
Regulation Number866.5270
Classification Product Code
DCK  
Date Received10/28/1994
Decision Date 03/09/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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