
Boehringer Mannheim Corp.
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CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH is an FDA 510(k)-cleared medical device (K954608) 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 December 25, 1995. Regulation: 8.