510(k) K170314

ACL AcuStar by Instrumentation Laboratory CO — Product Code JPA

K170314 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "ACL AcuStar". The FDA issued a decision of Substantially Equivalent on March 3, 2017. 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.