
Prodigy Diabetes Care, LLC
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PREFERRED BLOOD GLUCOSE MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K122338) manufactured by Prodigy Diabetes Care, LLC. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 4, 2013. Regulation: 8.