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FDA 510(k)

BCR-ABL1 (p210) % IS Kit (Digital PCR Method)

K-Number: K221869 · 2023-09-05

ApplicantSuzhou Sniper Medical Technologies Co., Ltd.
Decision Date2023-09-05
Product CodeOYX
Advisory CommitteeMG
DecisionSubstantially Equivalent

Device Summary

BCR-ABL1 (p210) % IS Kit (Digital PCR Method) is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Sniper Medical Technologies Co., Ltd.. It received FDA 510(k) clearance on 2023-09-05 under 510(k) number K221869. 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 BCR-ABL1 (p210) % IS Kit (Digital PCR Method)?

BCR-ABL1 (p210) % IS Kit (Digital PCR Method) is a medical device that received FDA 510(k) clearance on 2023-09-05. The listed applicant is Suzhou Sniper Medical Technologies Co., Ltd.. The 510(k) number is K221869.

When did BCR-ABL1 (p210) % IS Kit (Digital PCR Method) receive FDA 510(k) clearance?

BCR-ABL1 (p210) % IS Kit (Digital PCR Method) received FDA 510(k) clearance on 2023-09-05, under 510(k) number K221869.

Who is the listed applicant for BCR-ABL1 (p210) % IS Kit (Digital PCR Method)?

The FDA 510(k) record lists Suzhou Sniper Medical Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BCR-ABL1 (p210) % IS Kit (Digital PCR Method)?

The FDA product code for BCR-ABL1 (p210) % IS Kit (Digital PCR Method) 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;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.K173492MRDx 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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