K142501

Substantially Equivalent

Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System

Applicant: Cepheid
Product code: PCH
Advisory panel: Microbiology
Date received: 2014-09-05
Decision date: 2014-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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