Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K252243 · 2026-07-02

ApplicantSuzhou Precigenome, Ltd. Co;
Decision Date2026-07-02
Product CodeOYX
Advisory CommitteeMG
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: OYX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 SystemsCepheidK181661QXDx 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

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.

↑