ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II
FDA 510(k) clearance K093129 · decided 2010-04-28
Clearance details
- K-number
- K093129
- Device name
- ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II
- Applicant
- Illumina, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-10-02
- Decision date
- 2010-04-28
- Days to decision
- 208 days
- Clearance type
- Traditional
- Product code
- NPQ
- Device class
- 2
- Regulation number
- 864.7280
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| INVADER FACTOR V (K100980) | Hologic, Inc. | 2011-06-01 |
| ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING (K093974) | Osmetech Molecular Diagnostics | 2010-04-22 |
| XPERT HEMOSIL FACTOR II & FACTOR V ASSAY (K082118) | Cepheid | 2009-09-18 |
| INFINITI SYSTEM (K060564) | AutoGenomics, Inc. | 2007-02-07 |
| FACTOR V LEIDEN KIT (DEN030005) | Roche Diagnostics Corp. | 2003-12-17 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |
| Praxis Extended RAS Panel (P160038/S024) | Illumina, Inc. | 2023-01-13 |
| Praxis Extended RAS Panel (P160038/S023) | Illumina, Inc. | 2022-08-30 |