
U. S. Diagnostics, Inc.
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EASYGLUCO, MODEL IGM-0002 G2 is an FDA 510(k)-cleared medical device (K061431) manufactured by U. S. Diagnostics, Inc.. 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 January 11, 2007. Regulation: 8.