ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel— 510(k) K213236

Name: FDA 510(k) clearance K213236
Creator: U.S. Food and Drug Administration
Published: 2022-04-27

Substantially Equivalent

Genmark Diagnostics, Incorporated

FDA 510(k) clearance K213236 for ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel, Substantially Equivalent on 2022-04-27. Applicant: Genmark Diagnostics, Incorporated. Device class: 2.

Clearance details

Applicant: Genmark Diagnostics, Incorporated
Product code: Code PEN
Device class: Class 2
Regulation: 21 CFR 866.3365
Advisory panel: Microbiology
Date received: 2021-09-30
Decision date: 2022-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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K182690 — ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel2018-12-21
K181663 — ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel2018-12-20
K163636 — ePlex Respiratory Pathogen Panel2017-06-09
K163652 — ePlex Instrument2017-06-09
K152612 — eSensor Warfarin Sensitivity Saliva Test2016-05-26

Adverse events under product code PEN

product code PEN

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.