
Abbott Laboratories
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i-STAT PTplus Cartridge with the i-STAT 1 System is an FDA 510(k)-cleared medical device (K220282) manufactured by Abbott Laboratories. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 13, 2023. Regulation: 8.