COBAS READY LDH REAGENT

COBAS READY LDH REAGENT is an FDA 510(k)-cleared medical device (K896241) 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 15, 1990. Regulation: 8.