AT HOME DRUG TEST, MODEL 9063

AT HOME DRUG TEST, MODEL 9063 is an FDA 510(k)-cleared medical device (K994237) manufactured by Phamatech. 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 December 29, 1999. Regulation: 8.