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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name meningitis/encephalitis pathogen multiplex nucleic acid detection system
510(k) Number K160462
Device Name FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch
Applicant
BIOFIRE DIAGNOSTICS, LLC
390 WAKARA WAY
salt lake city,  UT  84108
Applicant Contact kristen j. kanack
Correspondent
BIOFIRE DIAGNOSTICS, LLC
390 WAKARA WAY
salt lake city,  UT  84108
Correspondent Contact kristen j. kanack
Regulation Number866.3970
Classification Product Code
PLO  
Date Received02/19/2016
Decision Date 03/17/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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