Source document or public record
FDA 510(k) K250003 — GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)
FDA 510(k) index record K250003. Device: GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005). Applicant as listed: Geneseeq Technology, Inc.. Decision date: 2025-08-29.
Source
"device_name": "GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K250003.
Device name: GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005). Applicant as listed: Geneseeq Technology, Inc..
Decision date: 2025-08-29. Decision wording: Substantially Equivalent.
Product code: PZM. Regulation: 21 CFR 866.6080. Medical specialty: Pathology.
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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