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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 K904603
Device Name QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM
Applicant
QUANTITATIVE MEDICINE, INC.
4955 WEST 145TH ST.
HAWTHORNE,  CA  90250
Applicant Contact S JOHNSON
Correspondent
QUANTITATIVE MEDICINE, INC.
4955 WEST 145TH ST.
HAWTHORNE,  CA  90250
Correspondent Contact S JOHNSON
Regulation Number862.1635
Classification Product Code
CEK  
Date Received10/10/1990
Decision Date 01/25/1991
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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