Documento fuente o registro público
FDA 510(k) K243374 — HemosIL CL HIT-IgG(PF4-H)
FDA 510(k) index record K243374. Device: HemosIL CL HIT-IgG(PF4-H). Applicant as listed: Instrumentation Laboratory (IL) Co.. Decision date: 2025-01-28.
Fuente
"device_name": "HemosIL CL HIT-IgG(PF4-H)"
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Automated FDA record verification
2026-10-20
2026-10-25
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FDA 510(k) public index record K243374.
Device name: HemosIL CL HIT-IgG(PF4-H). Applicant as listed: Instrumentation Laboratory (IL) Co..
Decision date: 2025-01-28. Decision wording: Substantially Equivalent.
Product code: LCO. Regulation: 21 CFR 864.7695. 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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