FDA product code NGG: Test, Methamphetamine, Over The Counter
NGG is the FDA product code for test, methamphetamine, over the counter. It is a Class II device, regulated under 21 CFR 862.3610 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under NGG. The average 510(k) review took 55 days (median 55). FDA has posted 1 recall for NGG devices.
Classification
| Field | Value |
|---|---|
| Device name | Test, Methamphetamine, Over The Counter |
| Device class | Class II |
| Regulation | 21 CFR 862.3610 |
| 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 NGG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 55 |
Compare with all 510(k) review times · Search every NGG clearance
Top NGG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Safecare Biotech (Hangzhou) Co., Ltd. | 1 | 2018-11-19 |
Most recent NGG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K182654 | Safecare Biotech (Hangzhou) Co., Ltd. | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card | 2018-11-19 | 55 |
Recalls for NGG devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-09-30.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code NGG?
NGG is the FDA product code for test, methamphetamine, over the counter. It is a Class II device, regulated under 21 CFR 862.3610 and reviewed by the Clinical Toxicology panel.
What device class is NGG?
Class II, regulation 21 CFR 862.3610. Typical premarket route: 510(k).
How long does a 510(k) take for product code NGG?
Across 1 cleared submissions the average was 55 days from receipt to decision (median 55).
Which companies have the most NGG clearances?
Safecare Biotech (Hangzhou) Co., Ltd. (1).
Have NGG devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-09-30.
Next steps
- Run an FDA pathway report with predicate devices for product code NGG
- Run a recall and safety report across every NGG manufacturer
- Watch product code NGG 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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