Xpert C. difficile/Epi— 510(k) K243730
Substantially EquivalentCepheid®
FDA 510(k) clearance K243730 for Xpert C. difficile/Epi, Substantially Equivalent on 2025-02-28. Applicant: Cepheid®. Device class: 2.
Clearance details
- Applicant
- Cepheid®
- Product code
- Code OZN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3130
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
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More clearances from Cepheid®
view allData sourced from openFDA. This site is unofficial and independent of the FDA.