510(k) K831625

UREA NITROGEN-BUN-REAGENTS B6360-12 by American Scientific Products — Product Code CDQ

K831625 is an FDA 510(k) premarket notification submitted by American Scientific Products for the device "UREA NITROGEN-BUN-REAGENTS B6360-12". The FDA issued a decision of Substantially Equivalent on July 7, 1983. The device falls under product code CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. American Scientific Products has at least 10 other 510(k) clearances on record.