FDA 510(k)

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)

K-Nummer: K191160 · 2019-11-04

AntragstellerLuminex Molecular Diagnostics, Inc.

Entscheidungsdatum2019-11-04

ProduktcodePCH

BeratungsausschussMI

EntscheidungSubstantially Equivalent

Produktübersicht

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Molecular Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-11-04 under 510(k) number K191160. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)?

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) is a medical device that received FDA 510(k) clearance on 2019-11-04. The listed applicant is Luminex Molecular Diagnostics, Inc.. The 510(k) number is K191160.

When did xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) receive FDA 510(k) clearance?

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) received FDA 510(k) clearance on 2019-11-04, under 510(k) number K191160.

Who is the listed applicant for xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)?

The FDA 510(k) record lists Luminex Molecular Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)?

The FDA product code for xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) is PCH.

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Weitere Einträge mit Luminex Molecular Diagnostics, Inc. als Antragsteller

K242613NxTAG® Respiratory Pathogen Panel K231758NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)K193167NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software K191161xTAG Gastrointestinal Pathogen Panel (GPP)K183023xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)K183030xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)

Alle 10 Geräte anzeigen →

Verwandte Geräte (Code: PCH)

K253722LIAISON PLEX Gastrointestinal Flex AssayLuminex Corporation K254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH K251721Xpert GI PanelCepheid K252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH K251868Panther Fusion GI Bacterial AssayHologic K251993Panther Fusion GI Expanded Bacterial AssayHologic, Inc.

Offizielle Quelle

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