510(k) K252684

Labcorp Fentanyl Urine Visual Test by Medtox Diagnostics, Inc. — Product Code DJG

K252684 is an FDA 510(k) premarket notification submitted by Medtox Diagnostics, Inc. for the device "Labcorp Fentanyl Urine Visual Test". The FDA issued a decision of Substantially Equivalent on January 29, 2026. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Medtox Diagnostics, Inc. has at least 10 other 510(k) clearances on record.