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FDA 510(k) Application Details - K132465
Device Classification Name
More FDA Info for this Device
510(K) Number
K132465
Device Name
BIOSIGN FLU A + B, STATUS FLU A & B
Applicant
PRINCETON BIOMEDITECH CORP.
4242 U.S. RT. 1
MONMOUTH JUNCTION, NJ 08852-1905 US
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Contact
KYUNG-AH KIM, PH.D.
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Regulation Number
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Classification Product Code
PSZ
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Date Received
08/07/2013
Decision Date
09/09/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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