510(k) K220282

i-STAT PTplus Cartridge with the i-STAT 1 System by Abbott Laboratories — Product Code GJS

K220282 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "i-STAT PTplus Cartridge with the i-STAT 1 System". The FDA issued a decision of Substantially Equivalent on July 14, 2023. The device falls under product code GJS (Test, Time, Prothrombin), a Class II device regulated under 21 CFR 864.7750. Abbott Laboratories has at least 10 other 510(k) clearances on record.