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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 a medical device manufactured by Genmark Diagnostics, Incorporated. It received FDA 510(k) clearance on 2018-12-20 under approval 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. It is manufactured by Genmark Diagnostics, Incorporated. The 510(k) number is K181663.

When was ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel approved by the FDA?

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

What company makes ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel?

ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel is manufactured by Genmark Diagnostics, Incorporated.

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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Other Devices by Genmark Diagnostics, Incorporated

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

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Related Devices (Code: PAM)

K152470Great Basin Staph ID/R Blood Culture PanelGreat Basin Scientific, Inc. K163390iC-GPC Assay TM for use on the iC-SystemTMIcubate, Inc. K243490LIAISON PLEX Gram-Positive Blood Culture AssayLuminex Corporation

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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