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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 K130500
Device Name CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT
Applicant
SEBIA
1705 CORPORATE DRIVE
SUITE 400
DULUTH,  GA  30093
Applicant Contact KAREN ANDERSON
Correspondent
SEBIA
1705 CORPORATE DRIVE
SUITE 400
DULUTH,  GA  30093
Correspondent Contact KAREN ANDERSON
Regulation Number862.1630
Classification Product Code
CEF  
Subsequent Product Codes
CFF   DEH   DFH  
Date Received02/26/2013
Decision Date 07/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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