
Wallac Oy, A Subsidiary of Perkinelmer
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NeoLSD MSMS kit is an FDA 510(k)-cleared medical device (K173829) manufactured by Wallac Oy, A Subsidiary of Perkinelmer. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 17, 2018. Regulation: 8.