STC AUTO-LYTE URINARY GLUCOSE ASSAY

STC AUTO-LYTE URINARY GLUCOSE ASSAY is an FDA 510(k)-cleared medical device (K962435) manufactured by OraSure Technologies, 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 December 25, 1996. Regulation: 8.