OPUS(R) TOXO-G TEST SYSTEM

OPUS(R) TOXO-G TEST SYSTEM is an FDA 510(k)-cleared medical device (K921523) manufactured by Pb Diagnostics, 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 September 13, 1992. Regulation: 8.