FETAL-TEK CONTROL (IMMATURE/BORDERLINE)

FETAL-TEK CONTROL (IMMATURE/BORDERLINE) is an FDA 510(k)-cleared medical device (K820772) manufactured by Helena Laboratories. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 11, 1982. Regulation: 8.