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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 -0022
Applicant Contact CARLOLYN K GEORGE
Correspondent
E.I. DUPONT DE NEMOURS & CO., INC.
BMP22/1170
WILMINGTON,  DE  19880 -0022
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
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