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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
Original Applicant
E.I. DUPONT DE NEMOURS & CO., INC.
bmp22/1170
wilmington,  DE  19880 0022
Original Contact carlolyn k george
Regulation Number862.1635
Classification Product Code
CEK  
Date Received10/08/1993
Decision Date 04/06/1994
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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