Source document or public record
FDA 510(k) K253957 — HemosIL Silica Clotting Time
FDA 510(k) index record K253957. Device: HemosIL Silica Clotting Time. Applicant as listed: Instrumentation Laboratory (IL) Co.. Decision date: 2026-01-09.
Source
"device_name": "HemosIL Silica Clotting Time"
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 K253957.
Device name: HemosIL Silica Clotting Time. Applicant as listed: Instrumentation Laboratory (IL) Co..
Decision date: 2026-01-09. Decision wording: Substantially Equivalent.
Product code: GFO. 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.
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