510(k) K942984

BUN REAGENT by American Research Products Co. — Product Code CDQ

K942984 is an FDA 510(k) premarket notification submitted by American Research Products Co. for the device "BUN REAGENT". The FDA issued a decision of Substantially Equivalent on March 1, 1995. The device falls under product code CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. American Research Products Co. has at least 10 other 510(k) clearances on record.