FDA 510(k)

ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel

Número K: K182690 · 2018-12-21

RequerenteGenmark Diagnostics, Incorporated

Data da decisão2018-12-21

Código do produtoPEO

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) 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 2018-12-21 under 510(k) number K182690. The device is classified under product code PEO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel?

ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel is a medical device that received FDA 510(k) clearance on 2018-12-21. The listed applicant is Genmark Diagnostics, Incorporated. The 510(k) number is K182690.

When did ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel receive FDA 510(k) clearance?

ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel received FDA 510(k) clearance on 2018-12-21, under 510(k) number K182690.

Who is the listed applicant for ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) 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 Fungal Pathogen (BCID-FP) Panel?

The FDA product code for ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel is PEO.

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

K213236ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel K182619ePlex Blood Culture Identification Gram Negative (BCID-GN) 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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Fonte oficial

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