TRICYCLICS SERUM TOX ASSAY

TRICYCLICS SERUM TOX ASSAY is an FDA 510(k)-cleared medical device (K961393) manufactured by Diagnostic Reagents, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 11, 1996. Regulation: 8.