510(k) K022072

PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS by Precision Systems, Inc. — Product Code CIX

K022072 is an FDA 510(k) premarket notification submitted by Precision Systems, Inc. for the device "PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS". The FDA issued a decision of Substantially Equivalent on August 23, 2002. The device falls under product code CIX (Bromcresol Green Dye-Binding, Albumin), a Class II device regulated under 21 CFR 862.1035. Precision Systems, Inc. has at least 2 other 510(k) clearances on record.