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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 a medical device manufactured by Bio-Rad Laboratories, Inc.. It received FDA 510(k) clearance on 2019-02-13 under approval 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. It is manufactured by Bio-Rad Laboratories, Inc.. The 510(k) number is K181661.

When was QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System approved by the FDA?

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

What company makes 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 manufactured by Bio-Rad Laboratories, Inc..

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.

Other Devices by Bio-Rad Laboratories, Inc.

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Related Devices (Code: OYX)

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Official Source

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

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