The following data is part of a De Novo classification by Xdx with the FDA for Allomap Molecular Expression Testing.
| DeNovo ID | DEN080007 |
| Device Name: | ALLOMAP MOLECULAR EXPRESSION TESTING |
| Classification | Cardiac Allograft Gene Expression Profiling Test System |
| Applicant | XDX 3260 Bayshore Boulevard Brisbane, CA 94005 |
| Contact | Rose Romeo |
| Product Code | OJQ |
| CFR Regulation Number | 862.1163 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K073482 |
| Review Advisory Board | Clinical Chemistry |
| Classification Advisory | Cardiovascular |
| Type | Post-NSE |
| Date Received | 2008-08-15 |
| Decision Date | 2008-08-26 |
| FDA Review | Decision Summary |
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