
Abbott Point of Care, Inc.
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i-Stat Alinity System with i-Stat Glucose test is an FDA 510(k)-cleared medical device (K163271) manufactured by Abbott Point of Care, 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 April 9, 2017. Regulation: 8.