510(k) K243405
- Device
- Xpert vanA
- Applicant
- Cepheid®
- 510(k) number
- K243405
- Product code
- NIJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-11-21
- Date received
- 2024-11-01
- Regulation
- 866.1640
- Classification name
- System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Suzette Chance
- Address
- 904 Caribbean Dr. Sunnyvale CA US 94089 94089
FDA Registration Numbers#
- 3016838963
- 3004530258
Source Documents#
Other 510(k) Records For Product Code NIJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K123753 | IMDX VANR FOR ABBOTT M2000 | Intelligent Medical Devices, Inc. | 2013-07-17 |
| K102416 | BD GENEOHM VANR ASSAY | Bd Diagnostics Science | 2011-10-20 |
| K092953 | Xpert VanA Assay | Cepheid | 2009-12-17 |
| K061686 | IDI-VANR ASSAY | Geneohm Sciences Canada, Inc. | 2006-08-30 |
| K020576 | VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE | Id Biomedical Corp. | 2002-05-01 |