FDA product code JLL: Tubeless Analysis, Gastric Acidity
JLL is the FDA product code for tubeless analysis, gastric acidity. It is a Class I device, regulated under 21 CFR 862.1320 and reviewed by the Clinical Chemistry panel. Devices under JLL reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Tubeless Analysis, Gastric Acidity |
| Device class | Class I |
| Regulation | 21 CFR 862.1320 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JLL devices
openFDA lists no recalls for product code JLL.
Frequently asked questions
What is FDA product code JLL?
JLL is the FDA product code for tubeless analysis, gastric acidity. It is a Class I device, regulated under 21 CFR 862.1320 and reviewed by the Clinical Chemistry panel.
What device class is JLL?
Class I, regulation 21 CFR 862.1320. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JLL
- Run a recall and safety report across every JLL manufacturer
- Watch product code JLL 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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