DEN240016
- 510(k) number
- DEN240016
- Device name
- Xpert HCV; GeneXpert Xpress System
- Applicant
- Cepheid CA · US
- Product code
- SBP — Simple Point-Of-Care Nucleic Acid-Based Hepatitis C
- Decision date
- 2024-06-27
- Date received
- 2024-04-16
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Microbiology
Official FDA record: DEN240016
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.