510(k) K052124

ACTICLOT, MODEL 824 by American Diagnostica, Inc. — Product Code GJS

K052124 is an FDA 510(k) premarket notification submitted by American Diagnostica, Inc. for the device "ACTICLOT, MODEL 824". The FDA issued a decision of Substantially Equivalent on October 17, 2005. The device falls under product code GJS (Test, Time, Prothrombin), a Class II device regulated under 21 CFR 864.7750. American Diagnostica, Inc. has at least 9 other 510(k) clearances on record.