ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN

ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN is an FDA 510(k)-cleared medical device (K964670) 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 February 3, 1997. Regulation: 8.