xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)— 510(k) K183023

Name: FDA 510(k) clearance K183023
Creator: U.S. Food and Drug Administration
Published: 2018-11-30

Substantially Equivalent

Luminex Molecular Diagnostics, Inc.

FDA 510(k) clearance K183023 for xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP), Substantially Equivalent on 2018-11-30. Applicant: Luminex Molecular Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Luminex Molecular Diagnostics, Inc.
Product code: Code PCH
Device class: Class 2
Regulation: 21 CFR 866.3990
Advisory panel: Microbiology
Date received: 2018-11-01
Decision date: 2018-11-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

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