510(k) K863901

IQ UREA NITROGEN by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JGZ

K863901 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "IQ UREA NITROGEN". The FDA issued a decision of Substantially Equivalent on November 24, 1986. The device falls under product code JGZ (O-Phthalaldehyde, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.