510(k) K233790

ACL TOP 970 CL by Instrumentation Laboratory — Product Code JPA

K233790 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory for the device "ACL TOP 970 CL". The FDA issued a decision of Substantially Equivalent on December 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 has at least 10 other 510(k) clearances on record.