STRATUS PRIMIDONE FLUOROMETRIC ENZYME

STRATUS PRIMIDONE FLUOROMETRIC ENZYME is an FDA 510(k)-cleared medical device (K904683) manufactured by Baxter Healthcare Corp. 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 November 27, 1990. Regulation: 8.