510(k) K223162

Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT by Healgen Scientific,, LLC — Product Code LDJ

K223162 is an FDA 510(k) premarket notification submitted by Healgen Scientific,, LLC for the device "Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT". The FDA issued a decision of Substantially Equivalent on March 17, 2023. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Healgen Scientific,, LLC has at least 10 other 510(k) clearances on record.