meddevicedb.com FDA Device Reference

ALLOMAP MOLECULAR EXPRESSION TESTING

DEN080007 Class II Post-NSE
Decision Date
2008-08-26
Sponsor / Applicant
Xdx

Technical Specification

510(k) Submission ID DEN080007
Product Code OJQ
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 862.1163
Decision Date 2008-08-26
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

ALLOMAP MOLECULAR EXPRESSION TESTING received FDA 510(k) clearance under submission number DEN080007, sponsored by Xdx. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2008-08-26.

Classification & Regulation

This clearance is catalogued under FDA product code OJQ and 21 CFR 862.1163, within the Cardiovascular review panel as a Class II device.