
Geometric Data, Div. Smithkline Corp.
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HEMATRAK MATURITY PROFILE OPTION is an FDA 510(k)-cleared medical device (K761208) manufactured by Geometric Data, Div. Smithkline Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 27, 1977. Regulation: 8.