
Gamma Biologicals, Inc.
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TEST, C-REATIVE PROTEIN, LATEX SLIDE is an FDA 510(k)-cleared medical device (K760035) manufactured by Gamma Biologicals, 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 August 2, 1976. Regulation: 8.