STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY

STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY is an FDA 510(k)-cleared medical device (K954326) manufactured by Solarcare Technologies Corp,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 July 22, 1996. Regulation: 8.