510(k) K161216

Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators by Immunalysis Corporation — Product Code DJG

K161216 is an FDA 510(k) premarket notification submitted by Immunalysis Corporation for the device "Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators". The FDA issued a decision of Substantially Equivalent on June 14, 2017. 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.