510(k) K210958

i-STAT CHEM8+ cartridge with the i-STAT 1 System by Abbott Point of Care, Inc. — Product Code CGA

K210958 is an FDA 510(k) premarket notification submitted by Abbott Point of Care, Inc. for the device "i-STAT CHEM8+ cartridge with the i-STAT 1 System". The FDA issued a decision of Substantially Equivalent on August 13, 2021. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Abbott Point of Care, Inc. has at least 10 other 510(k) clearances on record.