FITC GOAT ANTI-HUMAN IGG Y CHAIN

FITC GOAT ANTI-HUMAN IGG Y CHAIN is an FDA 510(k)-cleared medical device (K832264) manufactured by Gelco 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 October 27, 1983. Regulation: 8.