510(k) K213464

HemosIL Liquid Anti-Xa by Instrumentation Laboratory CO — Product Code KFF

K213464 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HemosIL Liquid Anti-Xa". The FDA issued a decision of Substantially Equivalent on October 4, 2022. The device falls under product code KFF (Assay, Heparin), a Class II device regulated under 21 CFR 864.7525. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.