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Diamond Diagnostics, Inc.
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BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT is an FDA 510(k)-cleared medical device (K033056) manufactured by Diamond Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 29, 2004. Regulation: 8.