ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES

ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES is an FDA 510(k)-cleared medical device (K951595) manufactured by Roche Diagnostic Systems, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 7, 1995. Regulation: 8.