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FDA 510(k) K233242 — Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)
FDA 510(k) index record K233242. Device: Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2024-01-18.
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"device_name": "Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)"
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 K233242.
Device name: Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2). Applicant as listed: Siemens Healthcare Diagnostics, Inc..
Decision date: 2024-01-18. Decision wording: Substantially Equivalent.
Product code: NQD. 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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