COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN

COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN is an FDA 510(k)-cleared medical device (K961824) manufactured by Roche Diagnostic Systems, 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 July 22, 1996. Regulation: 8.