ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY

ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY is an FDA 510(k)-cleared medical device (K881124) manufactured by Nichols Institute Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 17, 1988. Regulation: 8.