510(k) K252523

Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test by Healgen Scientific,, LLC — Product Code NFW

K252523 is an FDA 510(k) premarket notification submitted by Healgen Scientific,, LLC for the device "Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test". The FDA issued a decision of Substantially Equivalent on February 12, 2026. The device falls under product code NFW (Test, Cannabinoid, Over The Counter), a Class II device regulated under 21 CFR 862.3870. Healgen Scientific,, LLC has at least 10 other 510(k) clearances on record.