
Lifepoint,Inc
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IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE) is an FDA 510(k)-cleared medical device (K041746) 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 22, 2004. Regulation: 8.