TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I)— 510(k) K112781

Substantially Equivalent

Luminex Molecular Diagnostics, Inc.

FDA 510(k) clearance K112781 for TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I), Substantially Equivalent on 2012-02-17. Applicant: Luminex Molecular Diagnostics, Inc..

Clearance details

Applicant: Luminex Molecular Diagnostics, Inc.
Product code: Code OCC
Advisory panel: Microbiology
Date received: 2011-09-26
Decision date: 2012-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
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.