GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR

GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR is an FDA 510(k)-cleared medical device (K080662) manufactured by Genzyme Corporation. 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 May 14, 2008. Regulation: 8.