FDA 510(k)

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel

Numéro K : K182619 · 2019-04-12

DemandeurGenmark Diagnostics, Incorporated

Date de décision2019-04-12

Code produitPEN

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

ePlex Blood Culture Identification Gram Negative (BCID-GN) 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 2019-04-12 under 510(k) number K182619. The device is classified under product code PEN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel?

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel is a medical device that received FDA 510(k) clearance on 2019-04-12. The listed applicant is Genmark Diagnostics, Incorporated. The 510(k) number is K182619.

When did ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel receive FDA 510(k) clearance?

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel received FDA 510(k) clearance on 2019-04-12, under 510(k) number K182619.

Who is the listed applicant for ePlex Blood Culture Identification Gram Negative (BCID-GN) 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 Gram Negative (BCID-GN) Panel?

The FDA product code for ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel is PEN.

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Dispositifs connexes (Code : PEN)

K262168QIAstat-Dx BCID GN Plus AMR PanelQIAGEN GmbH K243013LIAISON PLEX Gram-Negative Blood Culture AssayLuminex Corporation K243759BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))Biofire Diagnostics, LLC K213236ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenmark Diagnostics, Incorporated K193519BioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLC K190341iC-GN iC-Cassette for use on the iC-SystemIcubate, Inc.

Source officielle

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