K103776

Substantially Equivalent

XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST

Applicant: Luminex Molecular Diagnostics, Inc.
Product code: OCC
Advisory panel: Microbiology
Date received: 2010-12-27
Decision date: 2011-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, Ontario, CA

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.