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Focus Diagnostics, Inc.
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3M INTEGRATED CYCLER (110V) & (220V) is an FDA 510(k)-cleared medical device (K102314) manufactured by Focus 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 October 28, 2010. Regulation: 8.