Xpert GI Panel— 510(k) K251721

Substantially Equivalent

Cepheid

FDA 510(k) clearance K251721 for Xpert GI Panel, Substantially Equivalent on 2026-01-16. Applicant: Cepheid.

Clearance details

Applicant: Cepheid
Product code: Code PCH
Advisory panel: Microbiology
Date received: 2025-06-04
Decision date: 2026-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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