AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL

AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL is an FDA 510(k)-cleared medical device (K920576) manufactured by Eastman Kodak Company. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 22, 1992. Regulation: 8.