XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)— 510(k) DEN130003

Name: FDA 510(k) clearance DEN130003
Creator: U.S. Food and Drug Administration
Published: 2013-01-14

Unknown

Luminex Molecular Diagnostics, Inc.

FDA 510(k) clearance DEN130003 for XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS), Unknown on 2013-01-14. 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: 2013-01-11
Decision date: 2013-01-14
Decision: Unknown
Clearance type: Post-NSE
Location: Toronto, CA

View on FDA.gov ↗

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