meddevicedb.com FDA Device Reference

ILLUMINA MISEQDX PLATFORM

DEN130011 Class II Post-NSE
Decision Date
2013-11-19
Sponsor / Applicant
Illumina, Inc.

Technical Specification

510(k) Submission ID DEN130011
Product Code PFF
Medical Specialty / Panel Immunology
Regulation Citation 21 CFR 862.2265
Decision Date 2013-11-19
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

ILLUMINA MISEQDX PLATFORM received FDA 510(k) clearance under submission number DEN130011, sponsored by Illumina, Inc.. 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 2013-11-19.

Classification & Regulation

This clearance is catalogued under FDA product code PFF and 21 CFR 862.2265, within the Immunology review panel as a Class II device.