Source document or public record
FDA 510(k) K241165 — Atellica® IM High-Sensitivity Troponin I (TnIH)
FDA 510(k) index record K241165. Device: Atellica® IM High-Sensitivity Troponin I (TnIH). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2024-07-25.
Source
"device_name": "Atellica® IM High-Sensitivity Troponin I (TnIH)"
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 K241165.
Device name: Atellica® IM High-Sensitivity Troponin I (TnIH). Applicant as listed: Siemens Healthcare Diagnostics, Inc..
Decision date: 2024-07-25. Decision wording: Substantially Equivalent.
Product code: MMI. Regulation: 21 CFR 862.1215. 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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