meddevicedb.com FDA Device Reference

TAG-IT CYSTIC FIBROSIS KIT

DEN050004 Class II Post-NSE
Decision Date
2005-05-09
Sponsor / Applicant
Tm Bioscience Corporation

Technical Specification

510(k) Submission ID DEN050004
Product Code NUA
Medical Specialty / Panel Immunology
Regulation Citation 21 CFR 866.5900
Decision Date 2005-05-09
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

TAG-IT CYSTIC FIBROSIS KIT received FDA 510(k) clearance under submission number DEN050004, sponsored by Tm Bioscience Corporation. 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 2005-05-09.

Classification & Regulation

This clearance is catalogued under FDA product code NUA and 21 CFR 866.5900, within the Immunology review panel as a Class II device.