NFW — Test, Cannabinoid, Over The Counter Class II

FDA Device Classification

Classification Details

Product Code
NFW
Device Class
Class II
Regulation Number
862.3870
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252523healgen scientificHealgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid DruFebruary 12, 2026
K231978vivachek biotech (hangzhou) coBioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ August 31, 2023
K192301shenzhen bioeasy biotechnology coBIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test StripSeptember 20, 2019
K191924safecare biotech (hangzhou) coSAFECARE® THC Urine Strip TestAugust 16, 2019