510(k) K061014

ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP by Helena Laboratories — Product Code JPA

K061014 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP". The FDA issued a decision of Substantially Equivalent on May 10, 2006. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Helena Laboratories has at least 10 other 510(k) clearances on record.