PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO

PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO is an FDA 510(k)-cleared medical device (K853865) manufactured by Pantex, Div. Bio-Analysis, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 14, 1985. Regulation: 8.