K190771

Substantially Equivalent

Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System

Applicant: Cepheid
Product code: NQX
Advisory panel: Microbiology
Date received: 2019-03-26
Decision date: 2019-04-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

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