Xpert Xpress CoV-2/Flu/RSV plus— 510(k) K242071

Substantially Equivalent

Cepheid

FDA 510(k) clearance K242071 for Xpert Xpress CoV-2/Flu/RSV plus, Substantially Equivalent on 2025-01-10. Applicant: Cepheid.

Clearance details

Applicant: Cepheid
Product code: Code QOF
Advisory panel: Microbiology
Date received: 2024-07-16
Decision date: 2025-01-10
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Sunnyvale, CA, US

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