510(k) K053110

Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge by I-Stat Corporation — Product Code JGS

K053110 is an FDA 510(k) premarket notification submitted by I-Stat Corporation for the device "Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge". The FDA issued a decision of Substantially Equivalent on January 13, 2006. The device falls under product code JGS (Electrode, Ion Specific, Sodium), a Class II device regulated under 21 CFR 862.1665. I-Stat Corporation has at least 6 other 510(k) clearances on record.