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FDA 510(k) Application Details - DEN200043
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN200043
Device Name
FilmArray Global Fever 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
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QMV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/26/2020
Decision Date
11/20/2020
Decision
DENG -
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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