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Bioimagene, Inc.
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PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS is an FDA 510(k)-cleared medical device (K080910) manufactured by Bioimagene, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 3, 2009. Regulation: 8.