THEOFAST(TM) TEST PACKAGE

THEOFAST(TM) TEST PACKAGE is an FDA 510(k)-cleared medical device (K863475) manufactured by 3M Company. 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 4, 1986. Regulation: 8.