
Dako Corp.
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DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION is an FDA 510(k)-cleared medical device (K951965) manufactured by Dako Corp.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 4, 1996. Regulation: 8.