AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY)

AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY) is an FDA 510(k)-cleared medical device (K896031) manufactured by Concord/Portex. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 11, 1990. Regulation: 8.