
Roche Diagnostics Corp.
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INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B is an FDA 510(k)-cleared medical device (K990595) 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 April 13, 1999. Regulation: 8.