UREA NITROGEN REAGENT SET

UREA NITROGEN REAGENT SET is an FDA 510(k)-cleared medical device (K813415) manufactured by Anco Medical Reagents & Assoc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 30, 1981. Regulation: 8.