FDA 510(k)

Fastplex™ BCR-ABL (p210) %IS digital PCR Kit

Numéro K : K252243 · 2026-07-02

Date de décision2026-07-02

Code produitOYX

Comité consultatifMG

DécisionSubstantially Equivalent

Résumé du dispositif

Fastplex™ BCR-ABL (p210) %IS digital PCR Kit is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Precigenome, Ltd. Co;. It received FDA 510(k) clearance on 2026-07-02 under 510(k) number K252243. 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 Fastplex™ BCR-ABL (p210) %IS digital PCR Kit?

Fastplex™ BCR-ABL (p210) %IS digital PCR Kit is a medical device that received FDA 510(k) clearance on 2026-07-02. The listed applicant is Suzhou Precigenome, Ltd. Co;. The 510(k) number is K252243.

When did Fastplex™ BCR-ABL (p210) %IS digital PCR Kit receive FDA 510(k) clearance?

Fastplex™ BCR-ABL (p210) %IS digital PCR Kit received FDA 510(k) clearance on 2026-07-02, under 510(k) number K252243.

Who is the listed applicant for Fastplex™ BCR-ABL (p210) %IS digital PCR Kit?

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

What is the FDA product code for Fastplex™ BCR-ABL (p210) %IS digital PCR Kit?

The FDA product code for Fastplex™ BCR-ABL (p210) %IS digital PCR Kit is OYX.

Essais cliniques associés

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Dispositifs connexes (Code : OYX)

K221869BCR-ABL1 (p210) % IS Kit (Digital PCR Method)Suzhou Sniper Medical Technologies Co., Ltd.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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