URYXXON RELAX URINE ANALYZER

URYXXON RELAX URINE ANALYZER is an FDA 510(k)-cleared medical device (K061742) manufactured by Macherey-Nagel GmbH & Co. KG. 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 September 5, 2006. Regulation: 8.