FDA 510(k)

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

Número K: K252243 · 2026-07-02

Data da decisão2026-07-02

Código do produtoOYX

Comité consultivoMG

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: 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

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.