
Abbott Point of Care, Inc.
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i-STAT CG8+ cartridge with the i-STAT 1 System is an FDA 510(k)-cleared medical device (K230275) 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 October 26, 2023. Regulation: 8.