
Alko Diagnostic Corp.
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CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT is an FDA 510(k)-cleared medical device (K955154) 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 December 10, 1995. Regulation: 8.