FDA product code JLN: Chromatographic, Glutathione
JLN is the FDA product code for chromatographic, glutathione. It is a Class I device, regulated under 21 CFR 862.1365 and reviewed by the Clinical Chemistry panel. Devices under JLN reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Chromatographic, Glutathione |
| Device class | Class I |
| Regulation | 21 CFR 862.1365 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JLN devices
openFDA lists no recalls for product code JLN.
Frequently asked questions
What is FDA product code JLN?
JLN is the FDA product code for chromatographic, glutathione. It is a Class I device, regulated under 21 CFR 862.1365 and reviewed by the Clinical Chemistry panel.
What device class is JLN?
Class I, regulation 21 CFR 862.1365. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JLN
- Run a recall and safety report across every JLN manufacturer
- Watch product code JLN 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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