Source document or public record
FDA 510(k) K262599 — Biolinq Shine Autonomous Time-in-Range Microsensor
FDA 510(k) index record K262599. Device: Biolinq Shine Autonomous Time-in-Range Microsensor. Applicant as listed: Biolinq Incorporated. Decision date: 2026-09-18.
Source
"device_name": "Biolinq Shine Autonomous Time-in-Range Microsensor"
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 K262599.
Device name: Biolinq Shine Autonomous Time-in-Range Microsensor. Applicant as listed: Biolinq Incorporated.
Decision date: 2026-09-18. Decision wording: Substantially Equivalent.
Product code: SFU. Regulation: 21 CFR 862.1359. Medical specialty: Clinical Chemistry.
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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