
Gen Trak, Inc.
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MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOM is an FDA 510(k)-cleared medical device (K922085) manufactured by Gen Trak, 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 27, 1992. Regulation: 8.