ALLOMAP MOLECULAR EXPRESSION TESTING

FDA 510(k) Premarket Notification · Submission DEN080007 · Applicant: Xdx

Public Record 510(k) Submission Decision Date: 2008-08-26 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification DEN080007.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

DEN080007

Applicant / Sponsor

Xdx

Device Name

ALLOMAP MOLECULAR EXPRESSION TESTING

Product Code

OJQ

Decision Date

2008-08-26

Decision / Status

Unknown (DENG)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Post-NSE

Third Party Flag

Date Received

2008-08-15

Related Establishments / Registrations

CareDx, Inc. Registration: 3005225997 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.