Xpert® FII & FV— 510(k) K250218

Substantially Equivalent

Cepheid

FDA 510(k) clearance K250218 for Xpert® FII & FV, Substantially Equivalent on 2025-02-21. Applicant: Cepheid.

Clearance details

Applicant: Cepheid
Product code: Code NPR
Advisory panel: Hematology
Date received: 2025-01-24
Decision date: 2025-02-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.