FDA 510(k)

Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems

Número K: K190076 · 2019-09-27

Data da decisão2019-09-27

Código do produtoOYX

Comité consultivoMG

DecisãoSubstantially Equivalent

Resumo do dispositivo

Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid. It received FDA 510(k) clearance on 2019-09-27 under 510(k) number K190076. The device is classified under product code OYX. It was reviewed by the MG advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems?

Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems is a medical device that received FDA 510(k) clearance on 2019-09-27. The listed applicant is Cepheid. The 510(k) number is K190076.

When did Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems receive FDA 510(k) clearance?

Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems received FDA 510(k) clearance on 2019-09-27, under 510(k) number K190076.

Who is the listed applicant for Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems?

The FDA 510(k) record lists Cepheid as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems?

The FDA product code for Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems is OYX.

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Fonte oficial

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