The following data is part of a De Novo classification by Affymetrix, Inc. with the FDA for Cytoscan(r) Dx.
| DeNovo ID | DEN130018 |
| Device Name: | CYTOSCAN(R) DX |
| Classification | System, Microarray-based, Genome-wide, Postnatal Chromosomal Abnormality Detection |
| Applicant | Affymetrix, Inc. 3420 Central Expressway Santa Clara, CA 95051 |
| Contact | Eric Fung |
| Product Code | PFX |
| CFR Regulation Number | 866.5920 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K130313 |
| Review Advisory Board | Pathology |
| Classification Advisory | Immunology |
| Type | Post-NSE |
| Date Received | 2013-12-18 |
| Decision Date | 2014-01-17 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |