
Horizon Diagnostics, Inc.
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BUN-300/BUN-500 UREA NITROGEN REAGENT is an FDA 510(k)-cleared medical device (K934533) manufactured by Horizon 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 November 25, 1993. Regulation: 8.