meddevicedb.com FDA Device Reference

FACTOR V LEIDEN KIT

DEN030005 Class II Post-NSE
Decision Date
2003-12-17
Sponsor / Applicant
Roche Diagnostics Corp.

Technical Specification

510(k) Submission ID DEN030005
Product Code NPQ
Medical Specialty / Panel Hematology
Regulation Citation 21 CFR 864.7280
Decision Date 2003-12-17
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

FACTOR V LEIDEN KIT received FDA 510(k) clearance under submission number DEN030005, sponsored by Roche Diagnostics Corp.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2003-12-17.

Classification & Regulation

This clearance is catalogued under FDA product code NPQ and 21 CFR 864.7280, within the Hematology review panel as a Class II device.