Source document or public record
FDA 510(k) K210858 — VITROS Chemistry Products PHBR Slides
FDA 510(k) index record K210858. Device: VITROS Chemistry Products PHBR Slides. Applicant as listed: Ortho-Clinical Diagnostics, Inc.. Decision date: 2021-08-13.
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"device_name": "VITROS Chemistry Products PHBR Slides"
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 K210858.
Device name: VITROS Chemistry Products PHBR Slides. Applicant as listed: Ortho-Clinical Diagnostics, Inc..
Decision date: 2021-08-13. Decision wording: Substantially Equivalent.
Product code: DLZ. Regulation: 21 CFR 862.3660. Medical specialty: Clinical Toxicology.
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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