meddevicedb.com FDA Device Reference

XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)

DEN130003 Class II Post-NSE
Decision Date
2013-01-14
Sponsor / Applicant
Luminex Molecular Diagnostics, Inc.

Technical Specification

510(k) Submission ID DEN130003
Product Code PCH
Medical Specialty / Panel Microbiology
Regulation Citation 21 CFR 866.3990
Decision Date 2013-01-14
Clearance Pathway Post-NSE

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS) received FDA 510(k) clearance under submission number DEN130003, sponsored by Luminex Molecular Diagnostics, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2013-01-14.

Classification & Regulation

This clearance is catalogued under FDA product code PCH and 21 CFR 866.3990, within the Microbiology review panel as a Class II device.