FDA 510(k)

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

K-Number: K173492 · 2017-12-22

Decision Date2017-12-22

Product CodeOYX

Advisory CommitteeMG

DecisionUnknown

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Molecularmd Corporation. The 510(k) number is K173492.

When was MRDx BCR-ABL Test, MRDx BCR-ABL Test Software approved by the FDA?

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

What company makes MRDx BCR-ABL Test, MRDx BCR-ABL Test Software?

MRDx BCR-ABL Test, MRDx BCR-ABL Test Software is manufactured by Molecularmd Corporation.

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.

Related Devices (Code: OYX)

DEN160003Quantidex qPCR BCR-ABL IS KitAsuragen, Inc. K190076Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 SystemsCepheid K181661QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemBio-Rad Laboratories, Inc. K221869BCR-ABL1 (p210) % IS Kit (Digital PCR Method)Suzhou Sniper Medical Technologies Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.