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FDA 510(k) Application Details - K170604
Device Classification Name
Respiratory Virus Panel Nucleic Acid Assay System
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510(K) Number
K170604
Device Name
Respiratory Virus Panel Nucleic Acid Assay System
Applicant
BioFire Diagnostics, LLC
515 Colorow Drive
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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Date Received
03/01/2017
Decision Date
05/30/2017
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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