
Kamiya Biomedical Co.
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K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C is an FDA 510(k)-cleared medical device (K042241) manufactured by Kamiya Biomedical Co.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 9, 2004. Regulation: 8.