510(k) K261039

i-STAT Crea cartridge with the i-STAT 1 System by Abbott Point of Care, Inc. — Product Code CGL

K261039 is an FDA 510(k) premarket notification submitted by Abbott Point of Care, Inc. for the device "i-STAT Crea cartridge with the i-STAT 1 System". The FDA issued a decision of Substantially Equivalent on June 26, 2026. The device falls under product code CGL (Electrode, Ion Based, Enzymatic, Creatinine), a Class II device regulated under 21 CFR 862.1225. Abbott Point of Care, Inc. has at least 10 other 510(k) clearances on record.