510(k) K051646

ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH by Pointe Scientific, Inc., — Product Code JGS

K051646 is an FDA 510(k) premarket notification submitted by Pointe Scientific, Inc., for the device "ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH". The FDA issued a decision of Substantially Equivalent on October 7, 2005. The device falls under product code JGS (Electrode, Ion Specific, Sodium), a Class II device regulated under 21 CFR 862.1665. Pointe Scientific, Inc., has at least 10 other 510(k) clearances on record.