UREA NITROGEN (ENZYMATIC) DETERMINATION

UREA NITROGEN (ENZYMATIC) DETERMINATION is an FDA 510(k)-cleared medical device (K822154) manufactured by The Dow Chemical Co.. 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 4, 1982. Regulation: 8.