The following data is part of a premarket notification filed by Affymetrix, Inc. with the FDA for Affymetrix Gene Profiling Reagents.
| Device ID | K103112 |
| 510k Number | K103112 |
| Device Name: | AFFYMETRIX GENE PROFILING REAGENTS |
| Classification | Complete Gene Expression Profiling Accessory Reagents |
| Applicant | Affymetrix, Inc. 3 LAGOON DRIVE SUITE 160 Redwood Shores, CA 94065 |
| Contact | Maureen Mende |
| Correspondent | Maureen Mende Affymetrix, Inc. 3 LAGOON DRIVE SUITE 160 Redwood Shores, CA 94065 |
| Product Code | OVA |
| CFR Regulation Number | 862.2570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-21 |
| Decision Date | 2011-05-04 |
| Summary: | summary |