Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K173492 · 2017-12-22

ApplicantMolecularmd Corporation
Decision Date2017-12-22
Product CodeOYX
Advisory CommitteeMG
DecisionUnknown

Device Summary

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.

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. 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.

Related Devices (Code: OYX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252243Fastplex™ BCR-ABL (p210) %IS digital PCR KitSuzhou Precigenome, Ltd. Co;K221869BCR-ABL1 (p210) % IS Kit (Digital PCR Method)Suzhou Sniper Medical Technologies Co., Ltd.K190076Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 SystemsCepheidK181661QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemBio-Rad Laboratories, Inc.

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.

↑