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FDA 510(k) Application Details - DEN160048
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN160048
Device Name
FilmArray NGDS Warrior Panel
Applicant
BioFire Defense, LLC
79 West 4500 South, Suite 14
Salt Lake City, UT 84107 US
Other 510(k) Applications for this Company
Contact
Cynthia Phillips
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Regulation Number
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Classification Product Code
PRD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/17/2016
Decision Date
02/14/2017
Decision
DENG -
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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