IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE)

IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE) is an FDA 510(k)-cleared medical device (K041747) manufactured by Lifepoint,Inc. 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 23, 2004. Regulation: 8.