The following data is part of a premarket notification filed by Illumina, Inc. with the FDA for Illumina Miseqdx Cystic Fibrosis 139-variant Assay.
| Device ID | K124006 |
| 510k Number | K124006 |
| Device Name: | ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY |
| Classification | System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection |
| Applicant | ILLUMINA, INC. 5200 ILLUMINA WAY San Diego, CA 92122 |
| Contact | Leanne M Kiviharju |
| Correspondent | Leanne M Kiviharju ILLUMINA, INC. 5200 ILLUMINA WAY San Diego, CA 92122 |
| Product Code | PFR |
| CFR Regulation Number | 866.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-26 |
| Decision Date | 2013-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816270020033 | K124006 | 000 |
| 00816270020378 | K124006 | 000 |
| 00816270020286 | K124006 | 000 |