Xpert Hemorrhagic Fever— 510(k) K253653

Substantially Equivalent

Cepheid

FDA 510(k) clearance K253653 for Xpert Hemorrhagic Fever, Substantially Equivalent on 2026-02-20. Applicant: Cepheid.

Clearance details

Applicant: Cepheid
Advisory panel: Unknown
Date received: 2025-11-20
Decision date: 2026-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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