Xpert HCV; GeneXpert Xpress System
FDA 510(k) clearance DEN240016 · decided 2024-06-27
Clearance details
- K-number
- DEN240016
- Device name
- Xpert HCV; GeneXpert Xpress System
- Applicant
- Cepheid
- Decision
- Unknown
- Date received
- 2024-04-16
- Decision date
- 2024-06-27
- Days to decision
- 72 days
- Clearance type
- Direct
- Product code
- SBP
- Device class
- 2
- Regulation number
- 866.3171
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.