meddevicedb.com FDA Device Reference

PAXGENE BLOOD RNA SYSTEM

DEN050003 Class II Post-NSE
Decision Date
2005-04-18
Sponsor / Applicant
Preanalytix GmbH

Technical Specification

510(k) Submission ID DEN050003
Product Code NTW
Medical Specialty / Panel Immunology
Regulation Citation 21 CFR 866.4070
Decision Date 2005-04-18
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

PAXGENE BLOOD RNA SYSTEM received FDA 510(k) clearance under submission number DEN050003, sponsored by Preanalytix GmbH. 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 2005-04-18.

Classification & Regulation

This clearance is catalogued under FDA product code NTW and 21 CFR 866.4070, within the Immunology review panel as a Class II device.