
Abbott Molecular, Inc.
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VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) is an FDA 510(k)-cleared medical device (DEN130010) manufactured by Abbott Molecular, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 28, 2013. Regulation: 8.