
Wallac OY
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PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM is an FDA 510(k)-cleared medical device (DEN140010) manufactured by Wallac OY. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 14, 2014. Regulation: 8.