The following data is part of a premarket notification filed by Affymetrix, Inc. with the FDA for Modification To Affymetrix Genechip Microarray Instrumentation System.
| Device ID | K080995 |
| 510k Number | K080995 |
| Device Name: | MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM |
| Classification | Instrumentation For Clinical Multiplex Test Systems |
| Applicant | Affymetrix, Inc. 3420 Central Expressway Santa Clara, CA 95051 |
| Contact | Maureen J Mende |
| Correspondent | Maureen J Mende Affymetrix, Inc. 3420 Central Expressway Santa Clara, CA 95051 |
| Product Code | NSU |
| CFR Regulation Number | 862.2570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-07 |
| Decision Date | 2008-07-30 |