HemosIL Silica Clotting Time— 510(k) K253957

Name: FDA 510(k) clearance K253957
Creator: U.S. Food and Drug Administration
Published: 2026-01-09

Substantially Equivalent

Instrumentation Laboratory (IL) Co.

FDA 510(k) clearance K253957 for HemosIL Silica Clotting Time, Substantially Equivalent on 2026-01-09. Applicant: Instrumentation Laboratory (IL) Co.. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory (IL) Co.
Product code: Code GFO
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 2025-12-10
Decision date: 2026-01-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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