The following data is part of a premarket notification filed by Illumina, Inc. with the FDA for Illumina Beadxpress System.
| Device ID | K093128 |
| 510k Number | K093128 |
| Device Name: | ILLUMINA BEADXPRESS SYSTEM |
| Classification | Instrumentation For Clinical Multiplex Test Systems |
| Applicant | ILLUMINA, INC. 5200 ILLUMINA WAY San Diego, CA 92122 |
| Contact | Donald R Ellis |
| Correspondent | Donald R Ellis ILLUMINA, INC. 5200 ILLUMINA WAY San Diego, CA 92122 |
| Product Code | NSU |
| CFR Regulation Number | 862.2570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-02 |
| Decision Date | 2010-04-28 |