Xpert Xpress CoV-2/Flu/RSV plus— 510(k) K250995

Substantially Equivalent

Cepheid®

FDA 510(k) clearance K250995 for Xpert Xpress CoV-2/Flu/RSV plus, Substantially Equivalent on 2025-05-01. Applicant: Cepheid®.

Clearance details

Applicant: Cepheid®
Product code: Code QOF
Advisory panel: Microbiology
Date received: 2025-04-01
Decision date: 2025-05-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

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