XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP)— 510(k) K140377

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

2014-02-14

Decision date

2014-09-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Toronto, Ontario, CA

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140377.