URYXXON 200 URINE ANALYZER

URYXXON 200 URINE ANALYZER is an FDA 510(k)-cleared medical device (K051034) 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 November 21, 2005. Regulation: 8.