COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS

COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS is an FDA 510(k)-cleared medical device (K891581) 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 August 14, 1989. Regulation: 8.