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Salimetrics, LLC
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HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 is an FDA 510(k)-cleared medical device (K011323) manufactured by Salimetrics, LLC. 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 16, 2001. Regulation: 8.