
Diabetes Technologies, Inc. (Dti)
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ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT is an FDA 510(k)-cleared medical device (K983172) manufactured by Diabetes Technologies, Inc. (Dti). 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 29, 1998. Regulation: 8.