Xpert C. difficile/Epi
FDA 510(k) clearance K243730 · decided 2025-02-28
Clearance details
- K-number
- K243730
- Device name
- Xpert C. difficile/Epi
- Applicant
- Cepheid®
- Decision
- Substantially Equivalent
- Date received
- 2024-12-03
- Decision date
- 2025-02-28
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- OZN
- Device class
- 2
- Regulation number
- 866.3130
- 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.