510(k) K260214

STA® - Liquid Anti-Xa by Diagnostica Stago, Inc. — Product Code KFF

K260214 is an FDA 510(k) premarket notification submitted by Diagnostica Stago, Inc. for the device "STA® - Liquid Anti-Xa". The FDA issued a decision of Substantially Equivalent on Sep 24, 2026. The device falls under product code KFF (Assay, Heparin), a Class II device regulated under 21 CFR 864.7525. Diagnostica Stago, Inc. has 21 other 510(k) clearances on record.