510(k) K944250

UREA NITROGEN REAGENT by Olympus Corp of America — Product Code CDQ

K944250 is an FDA 510(k) premarket notification submitted by Olympus Corp of America for the device "UREA NITROGEN REAGENT". The FDA issued a decision of Substantially Equivalent on February 8, 1995. The device falls under product code CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Olympus Corp of America has at least 1 other 510(k) clearance on record.