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Alko Diagnostic Corp.
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CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838 is an FDA 510(k)-cleared medical device (K001484) manufactured by Alko Diagnostic Corp.. 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 June 18, 2000. Regulation: 8.