510(k) K024182

PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS by Precision Systems, Inc. — Product Code CDQ

K024182 is an FDA 510(k) premarket notification submitted by Precision Systems, Inc. for the device "PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS". The FDA issued a decision of Substantially Equivalent on March 3, 2003. The device falls under product code CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Precision Systems, Inc. has at least 2 other 510(k) clearances on record.