ADVIA CHEMISTRY ENZYMATIC CREATININE_2

ADVIA CHEMISTRY ENZYMATIC CREATININE_2 is an FDA 510(k)-cleared medical device (K070727) manufactured by Siemens Medical Solutions Diagnostics. 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 2, 2007. Regulation: 8.