510(k) K230275

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

K230275 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 JGS (Electrode, Ion Specific, Sodium), a Class II device regulated under 21 CFR 862.1665. Abbott Point of Care, Inc. has at least 10 other 510(k) clearances on record.