The following data is part of a De Novo classification by Illumina, Inc. with the FDA for Illumina Miseqdx Platform.
| DeNovo ID | DEN130011 |
| Device Name: | ILLUMINA MISEQDX PLATFORM |
| Classification | High Throughput Dna Sequence Analyzer |
| Applicant | ILLUMINA, INC. 5200 Illumina Way San Diego, CA 92122 |
| Contact | Leanne M Kiviharju |
| Product Code | PFF |
| CFR Regulation Number | 862.2265 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K123989 |
| Review Advisory Board | Clinical Chemistry |
| Classification Advisory | Immunology |
| Type | Post-NSE |
| Date Received | 2013-09-23 |
| Decision Date | 2013-11-19 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816270020002 | DEN130011 | 000 |