FDA product code JLD: Chromatographic, Cystine
JLD is the FDA product code for chromatographic, cystine. It is a Class I device, regulated under 21 CFR 862.1240 and reviewed by the Clinical Chemistry panel. Devices under JLD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Chromatographic, Cystine |
| Device class | Class I |
| Regulation | 21 CFR 862.1240 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JLD devices
openFDA lists no recalls for product code JLD.
Frequently asked questions
What is FDA product code JLD?
JLD is the FDA product code for chromatographic, cystine. It is a Class I device, regulated under 21 CFR 862.1240 and reviewed by the Clinical Chemistry panel.
What device class is JLD?
Class I, regulation 21 CFR 862.1240. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JLD
- Run a recall and safety report across every JLD manufacturer
- Watch product code JLD 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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