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FDA 510(k) Application Details - K121633
Device Classification Name
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
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510(K) Number
K121633
Device Name
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Applicant
Becton, Dickinson and Company
10865 ROAD TO THE CURE,
SUITE 200
SAN DIEGO, CA 92064 US
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Contact
Gregory P Payne
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Regulation Number
866.3480
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Classification Product Code
GQG
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More FDA Info for this Product Code
Date Received
06/04/2012
Decision Date
09/18/2012
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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