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Drg Intl., Inc.
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ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL is an FDA 510(k)-cleared medical device (K051733) manufactured by Drg Intl., Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 6, 2005. Regulation: 8.