CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY

CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY is an FDA 510(k)-cleared medical device (K934562) manufactured by Ciba Corning Diagnostics Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 9, 1993. Regulation: 8.