
Kamiya Biomedical Co.
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K-ASSAY D-DIMER CONTROLS is an FDA 510(k)-cleared medical device (K012422) manufactured by Kamiya Biomedical Co.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 20, 2001. Regulation: 8.