ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS

ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS is an FDA 510(k)-cleared medical device (K850334) 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 March 13, 1985. Regulation: 8.