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FDA 510(k) Application Details - K151291
Device Classification Name
More FDA Info for this Device
510(K) Number
K151291
Device Name
BD Veritor (TM) System for the Rapid Detection of Flu A+B
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
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Classification Product Code
PSZ
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Date Received
05/15/2015
Decision Date
06/10/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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