COBAS READY ALBUMIN REAGENT

COBAS READY ALBUMIN REAGENT is an FDA 510(k)-cleared medical device (K896235) 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 February 26, 1990. Regulation: 8.