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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 K963018
Device Name BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS
Applicant
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547 -1803
Applicant Contact JOHN W NELSON
Correspondent
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547 -1803
Correspondent Contact JOHN W NELSON
Regulation Number862.1630
Classification Product Code
CEF  
Subsequent Product Code
JQT  
Date Received08/02/1996
Decision Date 06/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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