
Kamiya Biomedical Company, LLC
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K-ASSAY CRP (Ver.2) is an FDA 510(k)-cleared medical device (K242170) manufactured by Kamiya Biomedical Company, LLC. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 17, 2025. Regulation: 8.