510(k) K160445

HemosIL Silica Clotting Time by Instrumentation Laboratory CO — Product Code GFO

K160445 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HemosIL Silica Clotting Time". The FDA issued a decision of Substantially Equivalent on March 16, 2016. The device falls under product code GFO (Activated Partial Thromboplastin), a Class II device regulated under 21 CFR 864.7925. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.