Source document or public record
FDA 510(k) K242952 — INNOVANCE Antithrombin
FDA 510(k) index record K242952. Device: INNOVANCE Antithrombin. Applicant as listed: Siemens Healthcare Diagnostic Products GmbH. Decision date: 2025-03-28.
Source
"device_name": "INNOVANCE Antithrombin"
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 K242952.
Device name: INNOVANCE Antithrombin. Applicant as listed: Siemens Healthcare Diagnostic Products GmbH.
Decision date: 2025-03-28. Decision wording: Substantially Equivalent.
Product code: JBQ. Regulation: 21 CFR 864.7060. Medical specialty: Hematology.
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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