ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN

ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN is an FDA 510(k)-cleared medical device (K953528) 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 September 11, 1995. Regulation: 8.