meddevicedb.com FDA Device Reference

MISEQDX UNIVERSAL KIT 1.0

DEN130042 Class I Direct
Decision Date
2013-11-19
Sponsor / Applicant
Illumina, Inc.

Technical Specification

510(k) Submission ID DEN130042
Product Code PFT
Medical Specialty / Panel Clinical Chemistry
Regulation Citation 21 CFR 862.3800
Decision Date 2013-11-19
Clearance Pathway Direct

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

MISEQDX UNIVERSAL KIT 1.0 received FDA 510(k) clearance under submission number DEN130042, sponsored by Illumina, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2013-11-19.

Classification & Regulation

This clearance is catalogued under FDA product code PFT and 21 CFR 862.3800, within the Clinical Chemistry review panel as a Class I device.