OLYMPUS REPLY UREA NITROGEN REAGENT

OLYMPUS REPLY UREA NITROGEN REAGENT is an FDA 510(k)-cleared medical device (K931745) manufactured by Olympus Corp.. 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 August 18, 1993. Regulation: 8.