FDA product code NGO: Test, Triglycerides, Over The Counter
NGO is the FDA product code for test, triglycerides, over the counter. It is a Class I device, regulated under 21 CFR 862.1705 and reviewed by the Clinical Toxicology panel. Devices under NGO reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Test, Triglycerides, Over The Counter |
| Device class | Class I |
| Regulation | 21 CFR 862.1705 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NGO devices
openFDA lists no recalls for product code NGO.
Frequently asked questions
What is FDA product code NGO?
NGO is the FDA product code for test, triglycerides, over the counter. It is a Class I device, regulated under 21 CFR 862.1705 and reviewed by the Clinical Toxicology panel.
What device class is NGO?
Class I, regulation 21 CFR 862.1705. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NGO
- Run a recall and safety report across every NGO manufacturer
- Watch product code NGO 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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