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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biuret (Colorimetric), Total Protein
510(k) Number K950920
Device Name DUPONT DIMENSION TOTAL PROTEIN METHOD
Applicant
Dupont Medical Products
P.O. Box 80022, Bmp 22-1174
Wilmington,  DE  19880
Applicant Contact CATHY P CRAFT
Correspondent
Dupont Medical Products
P.O. Box 80022, Bmp 22-1174
Wilmington,  DE  19880
Correspondent Contact CATHY P CRAFT
Regulation Number862.1635
Classification Product Code
CEK  
Date Received03/01/1995
Decision Date 08/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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