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FDA 510(k) Application Details - K160068
Device Classification Name
Respiratory Virus Panel Nucleic Acid Assay System
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510(K) Number
K160068
Device Name
Respiratory Virus Panel Nucleic Acid Assay System
Applicant
BioFire Diagnostics, LLC
390 Wakara Way
Salt Lake City, UT 84108 US
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Contact
KRISTEN J. KANACK
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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
01/13/2016
Decision Date
02/08/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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