HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER

HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER is an FDA 510(k)-cleared medical device (K000701) manufactured by The Binding Site, Ltd.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 26, 2000. Regulation: 8.