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Roche Diagnostics Corp.
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COBAS 8000 MODULAR SERIES ANALYZER is an FDA 510(k)-cleared medical device (K100853) 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 September 8, 2010. Regulation: 8.