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FDA 510(k) Application Details - K063498
Device Classification Name
Alpha-1-Antitrypsin Kit, Qualitative Phenotype
More FDA Info for this Device
510(K) Number
K063498
Device Name
Alpha-1-Antitrypsin Kit, Qualitative Phenotype
Applicant
SEBIA
55 NORTHERN BLVD., SUITE 200
GREAT NECK, NY 11001 US
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Contact
KAREN ANDERSON
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Regulation Number
866.5130
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Classification Product Code
OBZ
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More FDA Info for this Product Code
Date Received
11/20/2006
Decision Date
06/11/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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