
Wallac Oy, A Subsidiary of Perkinelmer, Inc.
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GSP NEONATAL TOTAL GALACTOSE KIT is an FDA 510(k)-cleared medical device (K133652) manufactured by Wallac Oy, A Subsidiary of Perkinelmer, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 27, 2014. Regulation: 8.