510(k) K153357

i-STAT Alinity System with i-STAT Sodium test by Abbott Point of Care, Inc. — Product Code JGS

K153357 is an FDA 510(k) premarket notification submitted by Abbott Point of Care, Inc. for the device "i-STAT Alinity System with i-STAT Sodium test". The FDA issued a decision of Substantially Equivalent on July 8, 2016. 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.