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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 a medical device manufactured by Suzhou Sniper Medical Technologies Co., Ltd.. It received FDA 510(k) clearance on 2023-09-05 under approval 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. It is manufactured by Suzhou Sniper Medical Technologies Co., Ltd.. The 510(k) number is K221869.

When was BCR-ABL1 (p210) % IS Kit (Digital PCR Method) approved by the FDA?

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

What company makes BCR-ABL1 (p210) % IS Kit (Digital PCR Method)?

BCR-ABL1 (p210) % IS Kit (Digital PCR Method) is manufactured by Suzhou Sniper Medical Technologies Co., Ltd..

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.

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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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