
Ikonisys, Inc.
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ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 is an FDA 510(k)-cleared medical device (K080909) manufactured by Ikonisys, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 16, 2008. Regulation: 8.