FDA 510(k)

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel

Número K: K182619 · 2019-04-12

RequerenteGenmark Diagnostics, Incorporated

Data da decisão2019-04-12

Código do produtoPEN

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel is the device name listed in this FDA 510(k) record. The listed applicant is Genmark Diagnostics, Incorporated. It received FDA 510(k) clearance on 2019-04-12 under 510(k) number K182619. The device is classified under product code PEN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel?

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel is a medical device that received FDA 510(k) clearance on 2019-04-12. The listed applicant is Genmark Diagnostics, Incorporated. The 510(k) number is K182619.

When did ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel receive FDA 510(k) clearance?

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel received FDA 510(k) clearance on 2019-04-12, under 510(k) number K182619.

Who is the listed applicant for ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel?

The FDA 510(k) record lists Genmark Diagnostics, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel?

The FDA product code for ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel is PEN.

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Outros registros que listam Genmark Diagnostics, Incorporated como candidato(a)

K213236ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel K182690ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel K181663ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel K163636ePlex Respiratory Pathogen Panel K163652ePlex Instrument K152612eSensor Warfarin Sensitivity Saliva Test

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Dispositivos Relacionados (Código: PEN)

K262168QIAstat-Dx BCID GN Plus AMR PanelQIAGEN GmbH K243013LIAISON PLEX Gram-Negative Blood Culture AssayLuminex Corporation K243759BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))Biofire Diagnostics, LLC K213236ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenmark Diagnostics, Incorporated K193519BioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLC K190341iC-GN iC-Cassette for use on the iC-SystemIcubate, Inc.

Fonte oficial

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