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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 K852006
Device Name TP BIURET REAGENT
Applicant
ALPKEM CORP.
BOX 1260
CLACKAMAS,  OR  97015
Applicant Contact YOSIP F WARDA
Correspondent
ALPKEM CORP.
BOX 1260
CLACKAMAS,  OR  97015
Correspondent Contact YOSIP F WARDA
Regulation Number862.1635
Classification Product Code
CEK  
Date Received05/07/1985
Decision Date 06/10/1985
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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