The following data is part of a De Novo classification by Affymetrix, Inc. with the FDA for Affymetrix Genechip Microarray Instrumentation System.
| DeNovo ID | DEN040012 |
| Device Name: | AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM |
| Classification | Instrumentation For Clinical Multiplex Test Systems |
| Applicant | Affymetrix, Inc. 3380 Central Expressway Santa Clara, CA 95051 |
| Contact | Robert Lipshutz |
| Product Code | NSU |
| CFR Regulation Number | 862.2570 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K042279 |
| Review Advisory Board | Toxicology |
| Classification Advisory | Clinical Chemistry |
| Type | Post-NSE |
| Date Received | 2004-11-03 |
| Decision Date | 2004-12-23 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |