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Device Classification Name
mers-cov and common respiratory pathogens semi-quantitative and quantitative multiplex nucleic acid detection system
510(k) Number
K181324
Device Name
FilmArray Pneumonia Panel plus
Applicant
BioFire Diagnostics, LLC
515 Colorow Drive
Salt Lake City, UT 84108
Applicant Contact
Kristen J. Kanack
Correspondent
BioFire Diagnostics, LLC
515 Colorow Drive
Salt Lake City, UT 84108
Correspondent Contact
Kristen J. Kanack
Regulation Number
866.4001
Classification Product Code
QDS
Date Received
05/18/2018
Decision Date
11/15/2018
Decision
Substantially Equivalent (SESE)
Regulation Medical Specialty
Pathology
510k Review Panel
Microbiology
Summary
Summary
FDA Review
Decision Summary
Type
Traditional
Reviewed by Third Party
No
Combination Product
No
Recalls
CDRH Recalls
-
-