CEDIA ANTIBIOTIC TDM MULTI-CALS

CEDIA ANTIBIOTIC TDM MULTI-CALS is an FDA 510(k)-cleared medical device (K963191) manufactured by Boehringer Mannheim Corp.. 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 9, 1996. Regulation: 8.