
Roche Diagnostics Corp.
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C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS is an FDA 510(k)-cleared medical device (K053603) manufactured by Roche Diagnostics 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 February 8, 2006. Regulation: 8.