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FDA 510(k) Application Details - DEN200031
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN200031
Device Name
BioFire Respiratory Panel 2.1 (RP2.1)
Applicant
Biofire Diagnostics, LLC
515 Colorow Drive
Salt Lake City, UT 84108 US
Other 510(k) Applications for this Company
Contact
Kristen J Kanack
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QOF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/19/2020
Decision Date
03/17/2021
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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