ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM

ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM is an FDA 510(k)-cleared medical device (K863679) 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 October 15, 1986. Regulation: 8.