meddevicedb.com FDA Device Reference

LYRA DIRECT STREP ASSAY

DEN140005 Class II Post-NSE
Decision Date
2014-04-16
Sponsor / Applicant
Quidel Corporation

Technical Specification

510(k) Submission ID DEN140005
Product Code PGX
Medical Specialty / Panel Microbiology
Regulation Citation 21 CFR 866.2680
Decision Date 2014-04-16
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

LYRA DIRECT STREP ASSAY received FDA 510(k) clearance under submission number DEN140005, sponsored by Quidel Corporation. 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 2014-04-16.

Classification & Regulation

This clearance is catalogued under FDA product code PGX and 21 CFR 866.2680, within the Microbiology review panel as a Class II device.