COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C

COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C is an FDA 510(k)-cleared medical device (K851032) manufactured by Roche Diagnostic Systems, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 2, 1985. Regulation: 8.