
Smithkline Diagnostics, Inc.
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GASTROCCULT TM is an FDA 510(k)-cleared medical device (K821884) manufactured by Smithkline Diagnostics, 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 October 7, 1982. Regulation: 8.