Source document or public record
FDA 510(k) K223187 — HemosIL Liquid Anti-Xa
FDA 510(k) index record K223187. Device: HemosIL Liquid Anti-Xa. Applicant as listed: Instrumentation Laboratory CO. Decision date: 2023-06-23.
Source
"device_name": "HemosIL Liquid Anti-Xa"
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 K223187.
Device name: HemosIL Liquid Anti-Xa. Applicant as listed: Instrumentation Laboratory CO.
Decision date: 2023-06-23. 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.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.