FDA 510(k)

ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel

N.º K: K181663 · 2018-12-20

SolicitanteGenmark Diagnostics, Incorporated

Fecha de decisión2018-12-20

Código de productoPAM

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) 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 2018-12-20 under 510(k) number K181663. The device is classified under product code PAM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel?

ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel is a medical device that received FDA 510(k) clearance on 2018-12-20. The listed applicant is Genmark Diagnostics, Incorporated. The 510(k) number is K181663.

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

ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel received FDA 510(k) clearance on 2018-12-20, under 510(k) number K181663.

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

The FDA product code for ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel is PAM.

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Otros registros que enlistan a Genmark Diagnostics, Incorporated como solicitante

K213236ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel K182619ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel K182690ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel K163636ePlex Respiratory Pathogen Panel K163652ePlex Instrument K152612eSensor Warfarin Sensitivity Saliva Test

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Dispositivos relacionados (Código: PAM)

K254194QIAstat-Dx BCID GPF Plus AMR PanelQIAGEN GmbH K243490LIAISON PLEX Gram-Positive Blood Culture AssayLuminex Corporation K163390iC-GPC Assay TM for use on the iC-SystemTMIcubate, Inc.K152470Great Basin Staph ID/R Blood Culture PanelGreat Basin Scientific, Inc.

Fuente oficial

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