FDA 510(k)

MRDx BCR-ABL Test, MRDx BCR-ABL Test Software

Número K: K173492 · 2017-12-22

Data da decisão2017-12-22

Código do produtoOYX

Comité consultivoMG

DecisãoUnknown

Resumo do dispositivo

MRDx BCR-ABL Test, MRDx BCR-ABL Test Software is the device name listed in this FDA 510(k) record. The listed applicant is Molecularmd Corporation. It received FDA 510(k) clearance on 2017-12-22 under 510(k) number K173492. The device is classified under product code OYX. It was reviewed by the MG advisory panel. FDA Decision: Unknown.

Perguntas frequentes

What is the MRDx BCR-ABL Test, MRDx BCR-ABL Test Software?

MRDx BCR-ABL Test, MRDx BCR-ABL Test Software is a medical device that received FDA 510(k) clearance on 2017-12-22. The listed applicant is Molecularmd Corporation. The 510(k) number is K173492.

When did MRDx BCR-ABL Test, MRDx BCR-ABL Test Software receive FDA 510(k) clearance?

MRDx BCR-ABL Test, MRDx BCR-ABL Test Software received FDA 510(k) clearance on 2017-12-22, under 510(k) number K173492.

Who is the listed applicant for MRDx BCR-ABL Test, MRDx BCR-ABL Test Software?

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

What is the FDA product code for MRDx BCR-ABL Test, MRDx BCR-ABL Test Software?

The FDA product code for MRDx BCR-ABL Test, MRDx BCR-ABL Test Software is OYX.

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