RUBENOSTIKA IGG MICROELISA SYSTEM

RUBENOSTIKA IGG MICROELISA SYSTEM is an FDA 510(k)-cleared medical device (K911393) 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 April 28, 1991. Regulation: 8.