CIBA CORNING ACS LH IMMUNOASSAY

CIBA CORNING ACS LH IMMUNOASSAY is an FDA 510(k)-cleared medical device (K910198) 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 February 3, 1991. Regulation: 8.