
Wallac Oy, Subsidiary of Perkinelmer, Inc.
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NeoBase 2 Non-derivatized MSMS Kit is an FDA 510(k)-cleared medical device (K173568) manufactured by Wallac Oy, Subsidiary of Perkinelmer, Inc.. 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 September 3, 2018. Regulation: 8.