LUTEINIZING HORMONE DIRECT RIA KIT 125/I

LUTEINIZING HORMONE DIRECT RIA KIT 125/I is an FDA 510(k)-cleared medical device (K811024) manufactured by Immunalysis Corporation. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 7, 1981. Regulation: 8.