510(k) K221160— Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System

Substantially Equivalent

Cepheid

Clearance details

Applicant: Cepheid
Product code: Code PQA
Advisory panel: Microbiology
Date received: 2022-04-21
Decision date: 2022-06-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

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