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Genzyme Corp.
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GENZYME CONTRAST II HCG URINE/SERUM TEST is an FDA 510(k)-cleared medical device (K023544) manufactured by Genzyme Corp.. 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 15, 2003. Regulation: 8.