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Siemens Healthcare Diagnostics
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DIMENSIONS HB1C KIT, MODEL DF105A is an FDA 510(k)-cleared medical device (K102510) manufactured by Siemens Healthcare Diagnostics. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 12, 2011. Regulation: 8.