
Polymedco, Inc.
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POLY-CHEM 90 TOTAL BILIRUBIN is an FDA 510(k)-cleared medical device (K111143) manufactured by Polymedco, 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 August 31, 2011. Regulation: 8.