K143302

Substantially Equivalent

Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80

Applicant: Cepheid
Product code: PEU
Advisory panel: Microbiology
Date received: 2014-11-17
Decision date: 2015-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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