
Bayer Diagnostics Corp.
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BAYER RAPIDPOINT 405 SYSTEM is an FDA 510(k)-cleared medical device (K020616) manufactured by Bayer Diagnostics Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 16, 2002. Regulation: 8.