Source document or public record
FDA 510(k) K240315 — INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)
FDA 510(k) index record K240315. Device: INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05). Applicant as listed: Siemens Healthcare Diagnostics Products GmbH. Decision date: 2024-10-10.
Source
"device_name": "INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K240315.
Device name: INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05). Applicant as listed: Siemens Healthcare Diagnostics Products GmbH.
Decision date: 2024-10-10. Decision wording: Substantially Equivalent.
Product code: QLU. Regulation: 21 CFR 864.7295. 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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