K161619

Substantially Equivalent

Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems

Applicant: Cepheid
Product code: OUY
Advisory panel: Immunology
Date received: 2016-06-13
Decision date: 2016-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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