Source document or public record
FDA 510(k) K221197 — VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
FDA 510(k) index record K221197. Device: VITROS Immunodiagnostic Products Intact PTH II Reagent Pack. Applicant as listed: Ortho Clinical Diagnostics. Decision date: 2023-09-05.
Source
"device_name": "VITROS Immunodiagnostic Products Intact PTH 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 K221197.
Device name: VITROS Immunodiagnostic Products Intact PTH II Reagent Pack. Applicant as listed: Ortho Clinical Diagnostics.
Decision date: 2023-09-05. Decision wording: Substantially Equivalent.
Product code: CEW. Regulation: 21 CFR 862.1545. 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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