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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 K934841
Device Name URINARY/CEREBROSPINAL FLUID PROTEIN
Applicant
E.I. Dupont DE Nemours & Co., Inc.
Bmp22/1170
Wilmington,  DE  19880
Applicant Contact CARLOLYN K GEORGE
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
Bmp22/1170
Wilmington,  DE  19880
Correspondent Contact CARLOLYN K GEORGE
Regulation Number862.1635
Classification Product Code
CEK  
Date Received10/08/1993
Decision Date 04/06/1994
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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