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FDA 510(k)

QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

K-Number: K181661 · 2019-02-13

ApplicantBio-Rad Laboratories, Inc.
Decision Date2019-02-13
Product CodeOYX
Advisory CommitteeMG
DecisionSubstantially Equivalent

Device Summary

QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories, Inc.. It received FDA 510(k) clearance on 2019-02-13 under 510(k) number K181661. The device is classified under product code OYX. It was reviewed by the MG advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System?

QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System is a medical device that received FDA 510(k) clearance on 2019-02-13. The listed applicant is Bio-Rad Laboratories, Inc.. The 510(k) number is K181661.

When did QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System receive FDA 510(k) clearance?

QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System received FDA 510(k) clearance on 2019-02-13, under 510(k) number K181661.

Who is the listed applicant for QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System?

The FDA 510(k) record lists Bio-Rad Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System?

The FDA product code for QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System is OYX.

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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 SystemsCepheidK173492MRDx BCR-ABL Test, MRDx BCR-ABL Test SoftwareMolecularmd Corporation

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.

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