COBAS REAGENT FOR ALBUMIN

COBAS REAGENT FOR ALBUMIN is an FDA 510(k)-cleared medical device (K823574) manufactured by Hoffmann-La Roche, 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 January 6, 1983. Regulation: 8.