K203429

Substantially Equivalent

Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System

Applicant: Cepheid
Product code: NJR
Advisory panel: Microbiology
Date received: 2020-11-20
Decision date: 2022-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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