510(k) K203564

SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay by Immunalysis Corporation — Product Code DJG

K203564 is an FDA 510(k) premarket notification submitted by Immunalysis Corporation for the device "SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay". The FDA issued a decision of Substantially Equivalent on December 22, 2021. 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.