PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT

PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT is an FDA 510(k)-cleared medical device (K862483) 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 January 13, 1987. Regulation: 8.