ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY
FDA 510(k) clearance K124006 · decided 2013-11-19
Clearance details
- K-number
- K124006
- Device name
- ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY
- Applicant
- Illumina, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-12-26
- Decision date
- 2013-11-19
- Days to decision
- 328 days
- Clearance type
- Traditional
- Product code
- PFR
- Device class
- 2
- Regulation number
- 866.5900
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TruSight Oncology Comprehensive (P230011/S002) | Illumina, Inc. | 2026-06-26 |
| TruSight Oncology Comprehensive (P230011/S007) | Illumina, Inc. | 2026-04-23 |
| TruSight Oncology Comprehensive (P230011/S005) | Illumina, Inc. | 2025-09-19 |
| TruSight Oncology Comprehensive (P230011/S004) | Illumina, Inc. | 2025-09-05 |
| TruSight Oncology Comprehensive (P230011/S003) | Illumina, Inc. | 2025-04-18 |
| TruSight Oncology Comprehensive (P230011/S001) | Illumina, Inc. | 2024-11-07 |
| TruSight Oncology Comprehensive (P230011) | Illumina, Inc. | 2024-08-21 |
| Praxis Extended RAS Panel (P160038/S025) | Illumina, Inc. | 2023-02-17 |