KING DIAGNOSTICS UREA NITROGEN REAGENT

KING DIAGNOSTICS UREA NITROGEN REAGENT is an FDA 510(k)-cleared medical device (K922969) manufactured by King Diagnostics, Inc.. 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 October 12, 1992. Regulation: 8.