K250218

Substantially Equivalent

Xpert® FII & FV

Applicant: Cepheid
Product 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.