510(k) K253957

HemosIL Silica Clotting Time by Instrumentation Laboratory (IL) Co. — Product Code GFO

K253957 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory (IL) Co. for the device "HemosIL Silica Clotting Time". The FDA issued a decision of Substantially Equivalent on January 9, 2026. The device falls under product code GFO (Activated Partial Thromboplastin), a Class II device regulated under 21 CFR 864.7925. Instrumentation Laboratory (IL) Co. has at least 4 other 510(k) clearances on record.