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FDA 510(k) Application Details - K141927
Device Classification Name
Parainfluenza Multiplex Nucleic Acid Assay
More FDA Info for this Device
510(K) Number
K141927
Device Name
Parainfluenza Multiplex Nucleic Acid Assay
Applicant
QUIDEL CORPORATION
2005 E State St Suite 100
ATHENS, OH 45701 US
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Contact
Ronald H Lollar
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Regulation Number
866.3980
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Classification Product Code
OOU
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More FDA Info for this Product Code
Date Received
07/16/2014
Decision Date
10/09/2014
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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