Xpert C. difficile/Epi— 510(k) K243730

Substantially Equivalent

Cepheid®

FDA 510(k) clearance K243730 for Xpert C. difficile/Epi, Substantially Equivalent on 2025-02-28. Applicant: Cepheid®.

Clearance details

Applicant: Cepheid®
Product code: Code OZN
Advisory panel: Microbiology
Date received: 2024-12-03
Decision date: 2025-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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