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Syva Co., Dade Behring, Inc.
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EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229 is an FDA 510(k)-cleared medical device (K010812) manufactured by Syva Co., Dade Behring, 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 April 12, 2001. Regulation: 8.