
Kamiya Biomedical Co.
Free shipping on orders over $99 · 30-day returns
K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT is an FDA 510(k)-cleared medical device (K002948) 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 May 17, 2001. Regulation: 8.