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FDA 510(k) Applications for Medical Device Product Code "PEN"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K130914
BIOFIRE DIAGNOSTICS, INC.
FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL
06/21/2013
K193519
BioFire Diagnostics, LLC
BioFire Blood Culture Identification 2 (BCID2) Panel
03/18/2020
K181493
BioFire Diagnostics, LLC
FilmArray Blood Culture Identification (BCID) Panel
07/05/2018
K160457
BIOFIRE DIAGNOSTICS, LLC
FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch
03/15/2016
K143171
Biofire Diagnostics, LLC.
FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0
01/30/2015
K182619
GenMark Diagnostics, Incorporated
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
04/12/2019
K213236
GenMark Diagnostics, Incorporated
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
04/27/2022
K190341
iCubate, Inc.
iC-GN iC-Cassette for use on the iC-System
06/28/2019
K132843
NANOSPHERE, INC
VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
01/08/2014
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