FDA product code NGM: Test, Phencyclidine (Pcp), Over The Counter
NGM is the FDA product code for test, phencyclidine (pcp), over the counter. It is a Unclassified device, reviewed by the Clinical Toxicology panel. Devices under NGM reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
The phencyclidine test is an in vitro diagnostic test for the qualitative analysis of phencyclidine in human urine.
Classification
| Field | Value |
|---|---|
| Device name | Test, Phencyclidine (Pcp), Over The Counter |
| Device class | Unclassified |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
Recalls for NGM devices
openFDA lists no recalls for product code NGM.
Frequently asked questions
What is FDA product code NGM?
NGM is the FDA product code for test, phencyclidine (pcp), over the counter. It is a Unclassified device, reviewed by the Clinical Toxicology panel.
What device class is NGM?
Unclassified. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NGM
- Run a recall and safety report across every NGM manufacturer
- Watch product code NGM 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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