510(k) K944606

CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS by Beckman-Diagnostic Systems Group — Product Code DJG

K944606 is an FDA 510(k) premarket notification submitted by Beckman-Diagnostic Systems Group for the device "CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS". The FDA issued a decision of Substantially Equivalent on November 30, 1994. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Beckman-Diagnostic Systems Group has at least 10 other 510(k) clearances on record.