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510(k) K132843

Device
VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
Applicant
NANOSPHERE, INC
510(k) number
K132843
Product code
PEN  
Decision
Substantially Equivalent (SESE)
Decision date
2014-01-08
Date received
2013-09-10
Regulation
866.3365
Classification name
Gram-negative Bacteria And Associated Resistance Markers
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARK DEL VECCHIO
Address
4088 Commercial Ave. Northbrook IL US 60062 60062

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PEN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243013LIAISON PLEX Gram-Negative Blood Culture AssayLuminex Corporation2025-04-18
K243759BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))Biofire Diagnostics, LLC2024-12-20
K213236ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenmark Diagnostics, Incorporated2022-04-27
K193519BioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLC2020-03-18
K190341iC-GN iC-Cassette for use on the iC-SystemIcubate, Inc.2019-06-28
K182619ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenmark Diagnostics, Incorporated2019-04-12
K181493FilmArray Blood Culture Identification (BCID) PanelBiofire Diagnostics, LLC2018-07-05
K160457FilmArray Blood Culture Identification (BCID) panel for use with FilmArray TorchBiofire Diagnostics, LLC2016-03-15
K143171FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0Biofire Diagnostics, LLC2015-01-30
K130914FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANELBiofire Diagnostics, Inc.2013-06-21

Legacy Summary#

summary

FDA Review#

Decision Summary