510(k) K091980

ACL TOP 700 LAS by Instrumentation Laboratory CO — Product Code GKP

K091980 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "ACL TOP 700 LAS". The FDA issued a decision of Substantially Equivalent on September 22, 2009. The device falls under product code GKP (Instrument, Coagulation, Automated), a Class II device regulated under 21 CFR 864.5400. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.