
Abbott Point of Care, Inc.
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i-STAT CHEM8+ cartridge with the i-STAT 1 System is an FDA 510(k)-cleared medical device (K183680) manufactured by Abbott Point of Care, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 27, 2020. Regulation: 8.