510(k) K181135

Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay by Immunalysis Corporation — Product Code LCM

K181135 is an FDA 510(k) premarket notification submitted by Immunalysis Corporation for the device "Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay". The FDA issued a decision of Substantially Equivalent on January 24, 2019. The device falls under product code LCM (Enzyme Immunoassay, Phencyclidine), a Class U device. Immunalysis Corporation has at least 10 other 510(k) clearances on record.