
American Bioproducts Co.
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ASSERA PLATE IX:AG KIT is an FDA 510(k)-cleared medical device (K854014) manufactured by American Bioproducts Co.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 2, 1986. Regulation: 8.