FDA.report

510(k) K243759

Device
BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))
Applicant
Biofire Diagnostics, LLC
510(k) number
K243759
Product code
PEN
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-20
Date received
2024-12-06
Regulation
866.3365
Classification name
Gram-Negative Bacteria And Associated Resistance Markers
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Karli Plenert
Address
515 Colorow Dr. Salt Lake City UT US 84108 84108

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K143171FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0Biofire Diagnostics, LLC2015-01-30
K132843VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)Nanosphere, Inc.2014-01-08
K130914FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANELBiofire Diagnostics, Inc.2013-06-21