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Wallac OY
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NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B is an FDA 510(k)-cleared medical device (K071649) manufactured by Wallac OY. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 6, 2008. Regulation: 8.