Source document or public record
FDA 510(k) K241220 — Tina-quant Lipoprotein(a) Gen.2 Molarity
FDA 510(k) index record K241220. Device: Tina-quant Lipoprotein(a) Gen.2 Molarity. Applicant as listed: Roche Diagnostics Operations. Decision date: 2025-01-24.
Source
"device_name": "Tina-quant Lipoprotein(a) Gen.2 Molarity"
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 K241220.
Device name: Tina-quant Lipoprotein(a) Gen.2 Molarity. Applicant as listed: Roche Diagnostics Operations.
Decision date: 2025-01-24. Decision wording: Substantially Equivalent.
Product code: DFC. Regulation: 21 CFR 866.5600. Medical specialty: Immunology.
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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