510(k) K220451

Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT by Randox Laboratories Limited — Product Code DJG

K220451 is an FDA 510(k) premarket notification submitted by Randox Laboratories Limited for the device "Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT". The FDA issued a decision of Substantially Equivalent on October 5, 2023. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Randox Laboratories Limited has at least 10 other 510(k) clearances on record.