Cleared Special

HemosIL Silica Clotting Time

K253957 · Instrumentation Laboratory (IL) Co. · Hematology
Jan 2026
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K253957 is an FDA 510(k) clearance for the HemosIL Silica Clotting Time, a Activated Partial Thromboplastin (Class II — Special Controls, product code GFO), submitted by Instrumentation Laboratory (IL) Co. (Bedford, US). The FDA issued a Cleared decision on January 9, 2026, 30 days after receiving the submission on December 10, 2025. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K253957 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2025
Decision Date January 09, 2026
Days to Decision 30 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GFO — Activated Partial Thromboplastin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7925

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