FDA product code JLO: Enzymatic (Glutathione Reductase), Glutathione
JLO is the FDA product code for enzymatic (glutathione reductase), glutathione. It is a Class I device, regulated under 21 CFR 862.1365 and reviewed by the Clinical Chemistry panel. Devices under JLO reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Enzymatic (Glutathione Reductase), 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 JLO devices
openFDA lists no recalls for product code JLO.
Frequently asked questions
What is FDA product code JLO?
JLO is the FDA product code for enzymatic (glutathione reductase), glutathione. It is a Class I device, regulated under 21 CFR 862.1365 and reviewed by the Clinical Chemistry panel.
What device class is JLO?
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 JLO
- Run a recall and safety report across every JLO manufacturer
- Watch product code JLO 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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