ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL

ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL is an FDA 510(k)-cleared medical device (K991498) manufactured by Neometrics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 15, 1999. Regulation: 8.