FDA 510(k)

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

K-번호: K221869 · 2023-09-05

신청자Suzhou Sniper Medical Technologies Co., Ltd.

결정일2023-09-05

제품 코드OYX

자문 위원회MG

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

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

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: OYX)

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