Xpert® Xpress CoV-2 plus— 510(k) K230440

Substantially Equivalent

Cepheid®

FDA 510(k) clearance K230440 for Xpert® Xpress CoV-2 plus, Substantially Equivalent on 2023-10-13. Applicant: Cepheid®.

Clearance details

Applicant: Cepheid®
Product code: Code QQX
Advisory panel: Microbiology
Date received: 2023-02-21
Decision date: 2023-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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