K231381

Substantially Equivalent

Xpert Xpress MVP; GeneXpert Xpress System

Applicant: Cepheid
Product code: PQA
Advisory panel: Microbiology
Date received: 2023-05-12
Decision date: 2023-10-19
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Sunnyvale, CA, US

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