FDA Product Code NFW: Test, Cannabinoid, Over The Counter
Leading manufacturers include Shenzhen Bioeasy Biotechnology Co., Ltd., Vivachek Biotech (Hangzhou) Co., Ltd. and Healgen Scientific, LLC.
4
Total
4
Cleared
75d
Avg days
2019
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg
185d
recently vs 39d historically
FDA 510(k) Cleared Test, Cannabinoid, Over The Counter Devices (Product Code NFW)
4 devices
Cleared
Feb 12, 2026
Healgen® Accurate Oral Fluid Drug Test COT/THC
Healgen Scientific, LLC
Toxicology
185d
Cleared
Aug 31, 2023
BioSieve™ Marijuana Test Panel 50
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology
59d
Cleared
Sep 20, 2019
BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip
Shenzhen Bioeasy Biotechnology Co., Ltd.
Toxicology
28d
Cleared
Aug 16, 2019
SAFECARE® THC Urine Strip Test
Safecare Biotech (Hangzhou) Co., Ltd.
Toxicology
29d
About Product Code NFW - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code NFW since 2019, with 4 receiving FDA clearance (average review time: 75 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - NFW Product Code
Recent submissions under NFW have taken an average of 185 days to reach a decision - up from 39 days historically. Manufacturers should account for longer review timelines in current project planning.
NFW devices are reviewed by the Toxicology panel. Browse all Toxicology devices →