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FDA 510(k)

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

K-Number: K181663 · 2018-12-20

ApplicantGenmark Diagnostics, Incorporated
Decision Date2018-12-20
Product CodePAM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

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Other records listing Genmark Diagnostics, Incorporated as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213236ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelK182619ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelK182690ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) PanelK163652ePlex InstrumentK163636ePlex Respiratory Pathogen PanelK152612eSensor Warfarin Sensitivity Saliva Test

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Related Devices (Code: PAM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254194QIAstat-Dx BCID GPF Plus AMR PanelQIAGEN GmbHK243490LIAISON PLEX Gram-Positive Blood Culture AssayLuminex CorporationK163390iC-GPC Assay TM for use on the iC-SystemTMIcubate, Inc.K152470Great Basin Staph ID/R Blood Culture PanelGreat Basin Scientific, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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