XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP)— 510(k) K140647

Substantially Equivalent

Luminex Molecular Diagnostics, Inc.

FDA 510(k) clearance K140647 for XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP), Substantially Equivalent on 2014-10-24. Applicant: Luminex Molecular Diagnostics, Inc..

Clearance details

Applicant: Luminex Molecular Diagnostics, Inc.
Product code: Code PCH
Advisory panel: Microbiology
Date received: 2014-03-13
Decision date: 2014-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, Ontario, CA

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