510(k) K230285

i-STAT CG8+ cartridge with the i-STAT 1 System by Abbott Point of Care, Inc. — Product Code CHL

K230285 is an FDA 510(k) premarket notification submitted by Abbott Point of Care, Inc. for the device "i-STAT CG8+ cartridge with the i-STAT 1 System". The FDA issued a decision of Substantially Equivalent on October 27, 2023. The device falls under product code CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph), a Class II device regulated under 21 CFR 862.1120. Abbott Point of Care, Inc. has at least 10 other 510(k) clearances on record.