510(k) K221359

ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM by Instrumentation Laboratory CO — Product Code JPA

K221359 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM". The FDA issued a decision of Substantially Equivalent on September 29, 2023. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.