
Cooper Biomedical, Inc.
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IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO is an FDA 510(k)-cleared medical device (K864512) manufactured by Cooper Biomedical, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 12, 1987. Regulation: 8.