Xpert® FII & FV— 510(k) K223046

Substantially Equivalent

Cepheid®

FDA 510(k) clearance K223046 for Xpert® FII & FV, Substantially Equivalent on 2023-02-15. Applicant: Cepheid®.

Clearance details

Applicant: Cepheid®
Product code: Code NPR
Advisory panel: Hematology
Date received: 2022-09-29
Decision date: 2023-02-15
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.