FDA 510(k)

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

Número K: K181663 · 2018-12-20

RequerenteGenmark Diagnostics, Incorporated

Data da decisão2018-12-20

Código do produtoPAM

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Fonte oficial

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