Source document or public record
FDA 510(k) K192072 — Tina-quant C-Reactive Protein IV
FDA 510(k) index record K192072. Device: Tina-quant C-Reactive Protein IV. Applicant as listed: Roche Diagnostics Operations (Rdo). Decision date: 2020-02-21.
Source
"device_name": "Tina-quant C-Reactive Protein IV"
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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2026-10-20
2026-10-20
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FDA 510(k) public index record K192072.
Device name: Tina-quant C-Reactive Protein IV. Applicant as listed: Roche Diagnostics Operations (Rdo).
Decision date: 2020-02-21. Decision wording: Substantially Equivalent.
Product code: DCN. Regulation: 21 CFR 866.5270. 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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