Source document or public record
FDA 510(k) K252243 — Fastplex BCR-ABL (p210) %IS digital PCR Kit
FDA 510(k) index record K252243. Device: Fastplex BCR-ABL (p210) %IS digital PCR Kit. Applicant as listed: Suzhou Precigenome, Ltd. Co;. Decision date: 2026-07-02.
Source
"device_name": "Fastplex BCR-ABL (p210) %IS digital PCR Kit"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K252243.
Device name: Fastplex BCR-ABL (p210) %IS digital PCR Kit. Applicant as listed: Suzhou Precigenome, Ltd. Co;.
Decision date: 2026-07-02. Decision wording: Substantially Equivalent.
Product code: OYX. Regulation: 21 CFR 866.6060. Medical specialty: Medical Genetics.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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