XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST— 510(k) K103776

Name: FDA 510(k) clearance K103776
Creator: U.S. Food and Drug Administration
Published: 2011-07-01

Substantially Equivalent

Luminex Molecular Diagnostics, Inc.

FDA 510(k) clearance K103776 for XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST, Substantially Equivalent on 2011-07-01. Applicant: Luminex Molecular Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Luminex Molecular Diagnostics, Inc.
Product code: Code OCC
Device class: Class 2
Regulation: 21 CFR 866.3980
Advisory panel: Microbiology
Date received: 2010-12-27
Decision date: 2011-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, Ontario, CA

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OCC

product code OCC

Death: 3
Malfunction: 706
Total: 709

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.