510(k) K213211

Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System by Carolina Liquid Chemistries Corp. — Product Code DIO

K213211 is an FDA 510(k) premarket notification submitted by Carolina Liquid Chemistries Corp. for the device "Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System". The FDA issued a decision of Substantially Equivalent on January 27, 2022. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Carolina Liquid Chemistries Corp. has at least 10 other 510(k) clearances on record.