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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
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