THEOFAST TEST KIT FOR QUANTITATIVE THEO

THEOFAST TEST KIT FOR QUANTITATIVE THEO is an FDA 510(k)-cleared medical device (K834244) manufactured by Allergenetics. 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 January 23, 1984. Regulation: 8.