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FDA 510(k) Application Details - K101461
Device Classification Name
More FDA Info for this Device
510(K) Number
K101461
Device Name
BD DIRECTIGEN EX FLU A+B
Applicant
Becton, Dickinson and Company
11085 NORTH TORREY PINES ROAD
SUITE 210
LA JOLLA, CA 92037 US
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Contact
GREGORY PAYNE
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Regulation Number
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Classification Product Code
PSZ
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Date Received
05/26/2010
Decision Date
06/24/2010
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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