OLYMPUS UREA NITROGEN (BUN) REAGENT

OLYMPUS UREA NITROGEN (BUN) REAGENT is an FDA 510(k)-cleared medical device (K922597) 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 July 9, 1992. Regulation: 8.