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FDA 510(k) Application Details - K182157
Device Classification Name
More FDA Info for this Device
510(K) Number
K182157
Device Name
BioSign Flu A+B
Applicant
Princeton BioMeditech Corp.
4242 US Highway 1
Monmouth Junction, NJ 08852 US
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Contact
Kyung-ah Kim
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Regulation Number
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Classification Product Code
PSZ
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Date Received
08/09/2018
Decision Date
09/18/2018
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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