510(k) K863425

AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346 by American Research Products Co. — Product Code CDW

K863425 is an FDA 510(k) premarket notification submitted by American Research Products Co. for the device "AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346". The FDA issued a decision of Substantially Equivalent on October 1, 1986. The device falls under product code CDW (Diacetyl-Monoxime, 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.