PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY

PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY is an FDA 510(k)-cleared medical device (K102841) manufactured by Pantex, Div. Bio-Analysis, 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 May 7, 2012. Regulation: 8.