ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY
FDA 510(k) clearance K132750 · decided 2013-11-19
Clearance details
- K-number
- K132750
- Device name
- ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY
- Applicant
- Illumina, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-09-03
- Decision date
- 2013-11-19
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- PFS
- 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
+ Add to Predicate Builder ◉ Watch Illumina
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is recall (Z-0849-2015) | Illumina Inc | 2014-12-23 |
| Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for recall (Z-0850-2015) | Illumina Inc | 2014-12-23 |
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 |