Xpert Xpress CoV-2/Flu/RSV plus— 510(k) K231481

Substantially Equivalent

Cepheid®

FDA 510(k) clearance K231481 for Xpert Xpress CoV-2/Flu/RSV plus, Substantially Equivalent on 2023-08-17. Applicant: Cepheid®.

Clearance details

Applicant: Cepheid®
Product code: Code QOF
Advisory panel: Microbiology
Date received: 2023-05-23
Decision date: 2023-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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