STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I

STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I is an FDA 510(k)-cleared medical device (K853547) manufactured by American Dade. 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 September 15, 1985. Regulation: 8.