FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL

Gram-negative Bacteria And Associated Resistance Markers

BIOFIRE DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Biofire Diagnostics, Inc. with the FDA for Filmarray Blood Culture Identification (bcid) Panel.

Pre-market Notification Details

Device IDK130914
510k NumberK130914
Device Name:FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL
ClassificationGram-negative Bacteria And Associated Resistance Markers
Applicant BIOFIRE DIAGNOSTICS, INC. 390 Wakara Way Salt Lake City,  UT  84108
ContactBeth Lingenfelter
CorrespondentBeth Lingenfelter
BIOFIRE DIAGNOSTICS, INC. 390 Wakara Way Salt Lake City,  UT  84108
Product CodePEN  
Subsequent Product CodeOOI
Subsequent Product CodePAM
Subsequent Product CodePEO
CFR Regulation Number866.3365 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-02
Decision Date2013-06-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815381020093 K130914 000
00815381020086 K130914 000

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