
Sigma Diagnostics, Inc.
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SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 is an FDA 510(k)-cleared medical device (K013545) manufactured by Sigma 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 November 14, 2001. Regulation: 8.