meddevicedb.com FDA Device Reference

ID-TAG RESPIRATORY VIRAL PANEL

DEN070013 Class II Post-NSE
Decision Date
2008-01-03
Sponsor / Applicant
Luminex Molecular Diagnostics, Inc.

Technical Specification

510(k) Submission ID DEN070013
Product Code OCC
Medical Specialty / Panel Microbiology
Regulation Citation 21 CFR 866.3980
Decision Date 2008-01-03
Clearance Pathway Post-NSE

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

ID-TAG RESPIRATORY VIRAL PANEL received FDA 510(k) clearance under submission number DEN070013, sponsored by Luminex Molecular Diagnostics, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2008-01-03.

Classification & Regulation

This clearance is catalogued under FDA product code OCC and 21 CFR 866.3980, within the Microbiology review panel as a Class II device.