Xpert VanA Assay
FDA 510(k) clearance K092953 · decided 2009-12-17
Clearance details
- K-number
- K092953
- Device name
- Xpert VanA Assay
- Applicant
- Cepheid
- Decision
- Substantially Equivalent
- Date received
- 2009-09-24
- Decision date
- 2009-12-17
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- NIJ
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- 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 |
|---|---|---|
| Xpert vanA (K243405) | Cepheid® | 2024-11-21 |
| IMDX VANR FOR ABBOTT M2000 (K123753) | Intelligent Medical Devices, Inc. | 2013-07-17 |
| BD GENEOHM VANR ASSAY (K102416) | Bd Diagnostics Science | 2011-10-20 |
| IDI-VANR ASSAY (K061686) | Geneohm Sciences Canada, Inc. | 2006-08-30 |
| VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE (K020576) | Id Biomedical Corp. | 2002-05-01 |
Recalls involving this device
No recalls on record reference this clearance.