
Abbott Point of Care, Inc.
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i-STAT CG4+ cartridge with the i-STAT 1 System is an FDA 510(k)-cleared medical device (K244014) 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 May 1, 2025. Regulation: 8.