510(k) K851990

INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU by Alpkem Corp. — Product Code JIX

K851990 is an FDA 510(k) premarket notification submitted by Alpkem Corp. for the device "INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU". The FDA issued a decision of Substantially Equivalent on June 25, 1985. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Alpkem Corp. has at least 10 other 510(k) clearances on record.