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Catachem, Inc.
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CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT is an FDA 510(k)-cleared medical device (K062503) manufactured by Catachem, 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 18, 2007. Regulation: 8.