510(k) K190076— Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems

Substantially Equivalent

Cepheid

Clearance details

Applicant: Cepheid
Product code: Code OYX
Advisory panel: Medical Genetics
Date received: 2019-01-16
Decision date: 2019-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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