510(k) K200865

Piccolo Potassium Test System by Abaxis, Inc. — Product Code MZV

K200865 is an FDA 510(k) premarket notification submitted by Abaxis, Inc. for the device "Piccolo Potassium Test System". The FDA issued a decision of Substantially Equivalent on October 20, 2021. The device falls under product code MZV (Test, System, Potassium, Enzymatic Method), a Class II device regulated under 21 CFR 862.1600. Abaxis, Inc. has at least 10 other 510(k) clearances on record.