UREA NITROGEN-BUN-REAGENTS B6370-11A

UREA NITROGEN-BUN-REAGENTS B6370-11A is an FDA 510(k)-cleared medical device (K831626) manufactured by American Scientific Products. 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 6, 1983. Regulation: 8.