510(k) K880654

AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200 by American Research Products Co. — Product Code JIW

K880654 is an FDA 510(k) premarket notification submitted by American Research Products Co. for the device "AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200". The FDA issued a decision of Substantially Equivalent on June 7, 1988. The device falls under product code JIW (Calibrator, Surrogate), a Class II device regulated under 21 CFR 862.1150. American Research Products Co. has at least 10 other 510(k) clearances on record.