TOXONOSTIKA IGM MICROELISA SYSTEM

TOXONOSTIKA IGM MICROELISA SYSTEM is an FDA 510(k)-cleared medical device (K862196) manufactured by Organon Teknika Corp.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 10, 1986. Regulation: 8.