FDA product code JIG: Electrode, Ion-Specific Method, Ammonia
JIG is the FDA product code for electrode, ion-specific method, ammonia. It is a Class I device, regulated under 21 CFR 862.1065 and reviewed by the Clinical Chemistry panel. Devices under JIG reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Ion-Specific Method, Ammonia |
| Device class | Class I |
| Regulation | 21 CFR 862.1065 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for JIG devices
openFDA lists no recalls for product code JIG.
Frequently asked questions
What is FDA product code JIG?
JIG is the FDA product code for electrode, ion-specific method, ammonia. It is a Class I device, regulated under 21 CFR 862.1065 and reviewed by the Clinical Chemistry panel.
What device class is JIG?
Class I, regulation 21 CFR 862.1065. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code JIG
- Run a recall and safety report across every JIG manufacturer
- Watch product code JIG 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.
All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times