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FDA 510(k) Application Details - K083746
Device Classification Name
More FDA Info for this Device
510(K) Number
K083746
Device Name
BIOSIGN 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
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PSZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/17/2008
Decision Date
11/10/2010
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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