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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrophoretic, Protein Fractionation
510(k) Number K913315
Device Name BIO-RAD TOTAL PROTEIN TEST KIT
Applicant
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Applicant Contact SHARON K SMITH
Correspondent
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Correspondent Contact SHARON K SMITH
Regulation Number862.1630
Classification Product Code
CEF  
Date Received07/25/1991
Decision Date 01/02/1992
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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