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Kamiya Biomedical Co.
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K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL is an FDA 510(k)-cleared medical device (K093137) manufactured by Kamiya Biomedical Co.. 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 27, 2010. Regulation: 8.