IGE-QUANT DIAGNOSTIC TEST KIT

IGE-QUANT DIAGNOSTIC TEST KIT is an FDA 510(k)-cleared medical device (K831208) manufactured by Leeco Diagnostics, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 8, 1983. Regulation: 8.