BINDING SITE IGG SUBLCASS OLYMPUS KITS

BINDING SITE IGG SUBLCASS OLYMPUS KITS is an FDA 510(k)-cleared medical device (K042152) manufactured by The Binding Site. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 21, 2004. Regulation: 8.