meddevicedb.com FDA Device Reference

APTIMA TRICHOMONAS VAGINALIS ASSAY

DEN110012 Class II Post-NSE
Decision Date
2011-04-19
Sponsor / Applicant
Gen-Probe Incorporated

Technical Specification

510(k) Submission ID DEN110012
Product Code OUY
Medical Specialty / Panel Immunology
Regulation Citation 21 CFR 866.3860
Decision Date 2011-04-19
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

APTIMA TRICHOMONAS VAGINALIS ASSAY received FDA 510(k) clearance under submission number DEN110012, sponsored by Gen-Probe Incorporated. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2011-04-19.

Classification & Regulation

This clearance is catalogued under FDA product code OUY and 21 CFR 866.3860, within the Immunology review panel as a Class II device.