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FDA 510(k) Application Details - K122718
Device Classification Name
Antigens, All Groups, Streptococcus Spp.
More FDA Info for this Device
510(K) Number
K122718
Device Name
Antigens, All Groups, Streptococcus Spp.
Applicant
Becton, Dickinson and Company
10865 ROAD TO THE CURE,
SUITE 200
SAN DIEGO, CA 92121 US
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Contact
Gregory P Payne
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Regulation Number
866.3740
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Classification Product Code
GTY
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More FDA Info for this Product Code
Date Received
09/05/2012
Decision Date
02/06/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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