510(k) K253705

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

K253705 is an FDA 510(k) premarket notification submitted by Healgen Scientific,, LLC for the device "Healgen® Accurate Oral Fluid Drug Test". The FDA issued a decision of Substantially Equivalent on March 16, 2026. The device falls under product code DJC (Thin Layer Chromatography, Methamphetamine), a Class II device regulated under 21 CFR 862.3610. Healgen Scientific,, LLC has at least 10 other 510(k) clearances on record.