
Thermo Fisher Scientific
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CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS is an FDA 510(k)-cleared medical device (K081083) manufactured by Thermo Fisher Scientific. 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 December 18, 2008. Regulation: 8.