510(k) K191360

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

K191360 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 February 14, 2020. The device falls under product code JFP (Electrode, Ion Specific, Calcium), a Class II device regulated under 21 CFR 862.1145. Abbott Point of Care, Inc. has at least 10 other 510(k) clearances on record.