510(k) K151771

Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators by Immunalysis Corporation — Product Code JXM

K151771 is an FDA 510(k) premarket notification submitted by Immunalysis Corporation for the device "Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators". The FDA issued a decision of Substantially Equivalent on January 5, 2016. The device falls under product code JXM (Enzyme Immunoassay, Benzodiazepine), a Class II device regulated under 21 CFR 862.3170. Immunalysis Corporation has at least 10 other 510(k) clearances on record.