510(k) DEN240016
- Device
- Xpert HCV; GeneXpert Xpress System
- Applicant
- Cepheid
- 510(k) number
- DEN240016
- Product code
- SBP
- Decision
- Unknown (DENG)
- Decision date
- 2024-06-27
- Date received
- 2024-04-16
- Regulation
- 866.3171
- Classification name
- Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Suzette Chance
- Address
- 904 Caribbean Dr. Sunnyvale CA US 94089 94089
FDA Registration Numbers#
- 3016838963
- 3004530258
- 3009613136
Source Documents#
510(k) summary PDF not indicated by FDA