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FDA 510(k) Application Details - K163628
Device Classification Name
Respiratory Virus Panel Nucleic Acid Assay System
More FDA Info for this Device
510(K) Number
K163628
Device Name
Respiratory Virus Panel Nucleic Acid Assay System
Applicant
JANSSEN PHARMACEUTICA NV
TURNHOUTSEWEG 30
BEERSE 2340 BE
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Contact
SARAH PARSONS
Other 510(k) Applications for this Contact
Regulation Number
866.3980
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Classification Product Code
OCC
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More FDA Info for this Product Code
Date Received
12/22/2016
Decision Date
08/30/2017
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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