510(k) K161954

Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) by Siemens Healthcare Diagnostics — Product Code JGS

K161954 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)". The FDA issued a decision of Substantially Equivalent on March 9, 2017. The device falls under product code JGS (Electrode, Ion Specific, Sodium), a Class II device regulated under 21 CFR 862.1665. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.