Source document or public record
FDA 510(k) K233581 — VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
FDA 510(k) index record K233581. Device: VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack. Applicant as listed: Ortho Clinical Diagnostics. Decision date: 2024-05-08.
Source
"device_name": "VITROS Immunodiagnostic Products Total ß-hCG 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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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K233581.
Device name: VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack. Applicant as listed: Ortho Clinical Diagnostics.
Decision date: 2024-05-08. Decision wording: Substantially Equivalent.
Product code: DHA. Regulation: 21 CFR 862.1155. 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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