Source document or public record
FDA 510(k) K201312 — VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack
FDA 510(k) index record K201312. Device: VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack. Applicant as listed: Ortho Clinical Diagnostics. Decision date: 2021-10-04.
Source
"device_name": "VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack"
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 K201312.
Device name: VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack. Applicant as listed: Ortho Clinical Diagnostics.
Decision date: 2021-10-04. Decision wording: Substantially Equivalent.
Product code: NBC. Regulation: 21 CFR 862.1117. 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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