NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT

NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT is an FDA 510(k)-cleared medical device (K950481) manufactured by Isolab, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 31, 1996. Regulation: 8.