510(k) K863502

SOLUTION B- NA 50MEQ/L, K 40 MEQ/L by Reagent Laboratory, Inc. — Product Code JIX

K863502 is an FDA 510(k) premarket notification submitted by Reagent Laboratory, Inc. for the device "SOLUTION B- NA 50MEQ/L, K 40 MEQ/L". The FDA issued a decision of Substantially Equivalent on October 21, 1986. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Reagent Laboratory, Inc. has at least 10 other 510(k) clearances on record.