XTAG RESPIRATORY VIRAL PANEL— 510(k) K081483

Substantially Equivalent

Luminex Molecular Diagnostics, Inc.

FDA 510(k) clearance K081483 for XTAG RESPIRATORY VIRAL PANEL, Substantially Equivalent on 2008-06-25. Applicant: Luminex Molecular Diagnostics, Inc..

Clearance details

Applicant: Luminex Molecular Diagnostics, Inc.
Product code: Code OCC
Advisory panel: Microbiology
Date received: 2008-05-28
Decision date: 2008-06-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Toronto, Ontario, CA

Download summary PDF View on FDA.gov ↗

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.