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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 W. 145th St.
Hawthorne,  CA  90250
Applicant Contact S JOHNSON
Correspondent
Quantitative Medicine, Inc.
4955 W. 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
Predetermined Change
Control Plan Authorized		 No
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