PLATELIA TOXO IGM KIT

PLATELIA TOXO IGM KIT is an FDA 510(k)-cleared medical device (K894948) manufactured by Kallestad Diag, A Div. of Erbamont, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 14, 1990. Regulation: 8.