
Bayer Corp.
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THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM is an FDA 510(k)-cleared medical device (K980376) 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 April 22, 1998. Regulation: 8.