FDA 510(k)

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

Numéro K : K221869 · 2023-09-05

DemandeurSuzhou Sniper Medical Technologies Co., Ltd.

Date de décision2023-09-05

Code produitOYX

Comité consultatifMG

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : OYX)

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 SystemsCepheid K181661QXDx 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

Source officielle

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