
Kamiya Biomedical Co.
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K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C is an FDA 510(k)-cleared medical device (K030687) 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 June 26, 2003. Regulation: 8.