Xpert Xpress MVP; GeneXpert Xpress System— 510(k) K231381
Substantially EquivalentCepheid
FDA 510(k) clearance K231381 for Xpert Xpress MVP; GeneXpert Xpress System, Substantially Equivalent on 2023-10-19. Applicant: Cepheid.
Clearance details
- Applicant
- Cepheid
- Product code
- Code PQA
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Location
- Sunnyvale, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.