
Bayer Corp.
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BAYER IMMUNO 1 HER-2/NEU ASSAY is an FDA 510(k)-cleared medical device (K992228) manufactured by Bayer Corp.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 28, 2000. Regulation: 8.