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FDA 510(k) Application Details - K130500
Device Classification Name
Electrophoretic, Protein Fractionation
More FDA Info for this Device
510(K) Number
K130500
Device Name
Electrophoretic, Protein Fractionation
Applicant
SEBIA
1705 CORPORATE DRIVE
SUITE 400
DULUTH, GA 30093 US
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Contact
KAREN ANDERSON
Other 510(k) Applications for this Contact
Regulation Number
862.1630
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Classification Product Code
CEF
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More FDA Info for this Product Code
Date Received
02/26/2013
Decision Date
07/26/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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