FDA product code NFW: Test, Cannabinoid, Over The Counter
NFW is the FDA product code for test, cannabinoid, over the counter. It is a Class II device, regulated under 21 CFR 862.3870 and reviewed by the Clinical Toxicology panel. FDA has cleared 4 510(k) submissions under NFW, 2 in the last five years, from 4 different applicants. The average 510(k) review took 75 days (median 44); 185 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Test, Cannabinoid, Over The Counter |
| Device class | Class II |
| Regulation | 21 CFR 862.3870 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NFW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 2 | 28 |
| 2023 | 1 | 59 |
| 2026 | 1 | 185 |
Compare with all 510(k) review times · Search every NFW clearance
Top NFW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Healgen Scientific,, LLC | 1 | 2026-02-12 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | 1 | 2023-08-31 |
| Shenzhen Bioeasy Biotechnology Co., Ltd. | 1 | 2019-09-20 |
| Safecare Biotech (Hangzhou) Co., Ltd. | 1 | 2019-08-16 |
Most recent NFW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252523 | Healgen Scientific,, LLC | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test | 2026-02-12 | 185 |
| K231978 | Vivachek Biotech (Hangzhou) Co., Ltd. | BioSieve Marijuana Test Panel 50; BioSieve Marijuana Test Strip 50; BioSieve Dx Marijuana Test Strip 20; BioSieve Dx Marijuana Test Strip 50; BioSieve Dx Marijuana Test Panel 20; BioSieve Dx Marijuana Test Panel 50 | 2023-08-31 | 59 |
| K192301 | Shenzhen Bioeasy Biotechnology Co., Ltd. | BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip | 2019-09-20 | 28 |
| K191924 | Safecare Biotech (Hangzhou) Co., Ltd. | SAFECARE® THC Urine Strip Test | 2019-08-16 | 29 |
Recalls for NFW devices
openFDA lists no recalls for product code NFW.
Frequently asked questions
What is FDA product code NFW?
NFW is the FDA product code for test, cannabinoid, over the counter. It is a Class II device, regulated under 21 CFR 862.3870 and reviewed by the Clinical Toxicology panel.
What device class is NFW?
Class II, regulation 21 CFR 862.3870. Typical premarket route: 510(k).
How long does a 510(k) take for product code NFW?
Across 4 cleared submissions the average was 75 days from receipt to decision (median 44).
Which companies have the most NFW clearances?
Healgen Scientific,, LLC (1); Vivachek Biotech (Hangzhou) Co., Ltd. (1); Shenzhen Bioeasy Biotechnology Co., Ltd. (1); Safecare Biotech (Hangzhou) Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NFW
- Run a recall and safety report across every NFW manufacturer
- Watch product code NFW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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