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FDA 510(k) Application Details - K222601
Device Classification Name
More FDA Info for this Device
510(K) Number
K222601
Device Name
FilmArray Pneumonia Panel plus
Applicant
BioFire Diagnostics, LLC
515 Colorow Drive
Salt Lake City, UT 84108 US
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Contact
Kevin Bourzac
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Regulation Number
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Classification Product Code
QDS
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More FDA Info for this Product Code
Date Received
08/29/2022
Decision Date
10/27/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PA - Pathology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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