Source document or public record
FDA 510(k) K260551 — HemosIL Factor V Leiden (APC Resistance V)
FDA 510(k) index record K260551. Device: HemosIL Factor V Leiden (APC Resistance V). Applicant as listed: Instrumentation Laboratory (IL) Co.. Decision date: 2026-03-20.
Source
"device_name": "HemosIL Factor V Leiden (APC Resistance V)"
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 K260551.
Device name: HemosIL Factor V Leiden (APC Resistance V). Applicant as listed: Instrumentation Laboratory (IL) Co..
Decision date: 2026-03-20. Decision wording: Substantially Equivalent.
Product code: GGW. Regulation: 21 CFR 864.7925. 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.