FDA product code NGK: Test, Occult Blood, Over The Counter
NGK is the FDA product code for test, occult blood, over the counter. It is a Class II device, regulated under 21 CFR 864.6550 and reviewed by the Clinical Toxicology panel. Devices under NGK reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Test, Occult Blood, Over The Counter |
| Device class | Class II |
| Regulation | 21 CFR 864.6550 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NGK devices
openFDA lists no recalls for product code NGK.
Frequently asked questions
What is FDA product code NGK?
NGK is the FDA product code for test, occult blood, over the counter. It is a Class II device, regulated under 21 CFR 864.6550 and reviewed by the Clinical Toxicology panel.
What device class is NGK?
Class II, regulation 21 CFR 864.6550. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NGK
- Run a recall and safety report across every NGK manufacturer
- Watch product code NGK 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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