Source document or public record
FDA 510(k) K260827 — Oncomine Dx Express Test
FDA 510(k) index record K260827. Device: Oncomine Dx Express Test. Applicant as listed: Life Technologies Corporation. Decision date: 2026-10-15.
Source
"device_name": "Oncomine Dx Express Test"
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
2026-10-27
2026-10-27
professional use
FDA 510(k) public index record K260827.
Device name: Oncomine Dx Express Test. Applicant as listed: Life Technologies Corporation.
Decision date: 2026-10-15. Decision wording: Substantially Equivalent.
Product code: SBY. Regulation: 21 CFR 866.6085. 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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