510(k) K252520

SEFRIA™ Hydrocodone Oral Fluid by Immunalysis Corporation — Product Code DJG

K252520 is an FDA 510(k) premarket notification submitted by Immunalysis Corporation for the device "SEFRIA™ Hydrocodone Oral Fluid". The FDA issued a decision of Substantially Equivalent on September 11, 2025. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Immunalysis Corporation has at least 10 other 510(k) clearances on record.