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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 K832169
Device Name TOTAL PROTEIN PROCEDURE
Original Applicant
SANDARE CHEMICAL CO., INC.
Regulation Number862.1635
Classification Product Code
CEK  
Date Received07/06/1983
Decision Date 08/16/1983
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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