NFW

Test, Cannabinoid, Over The Counter

Product code
NFW
Device name
Test, Cannabinoid, Over The Counter
Device class
Class 2
21 CFR
21 CFR 862.3870
Medical specialty
Clinical Toxicology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
4 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-02-12.

NumberDecision dateApplicantDevice nameSummary
K2525232026-02-12Healgen Scientific,, LLCHealgen® Accurate Oral Fluid Drug Test COT/THC; HealPDF

1 summaries are archived here for direct download.

Official FDA classification page: NFW
Classification and pathway per current FDA publications. Data from openFDA (CC0).