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FDA 510(k) Application Details - K151226
Device Classification Name
Respiratory Virus Panel Nucleic Acid Assay System
More FDA Info for this Device
510(K) Number
K151226
Device Name
Respiratory Virus Panel Nucleic Acid Assay System
Applicant
CEPHEID
904 CARIBBEAN DRIVE
Sunnyvale, CA 94089 US
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Contact
Kerry J Flom
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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
05/07/2015
Decision Date
12/03/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Dual Track
Reviewed By Third Party
N
Expedited Review
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