XPERT HEMOSIL FACTOR II & FACTOR V ASSAY
FDA 510(k) clearance K082118 · decided 2009-09-18
Clearance details
- K-number
- K082118
- Device name
- XPERT HEMOSIL FACTOR II & FACTOR V ASSAY
- Applicant
- Cepheid
- Decision
- Substantially Equivalent
- Date received
- 2008-07-28
- Decision date
- 2009-09-18
- Days to decision
- 417 days
- Clearance type
- Traditional
- Product code
- NPQ
- Device class
- 2
- Regulation number
- 864.7280
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Sunnyvale, 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 |
| ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II (K093129) | Illumina, Inc. | 2010-04-28 |
| ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING (K093974) | Osmetech Molecular Diagnostics | 2010-04-22 |
| 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.