FDA product code CJB: Chromatographic Separation/Radioimmunoassay, Aldosterone
CJB is the FDA product code for chromatographic separation/radioimmunoassay, aldosterone. It is a Class II device, regulated under 21 CFR 862.1045 and reviewed by the Clinical Chemistry panel. Devices under CJB reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Chromatographic Separation/Radioimmunoassay, Aldosterone |
| Device class | Class II |
| Regulation | 21 CFR 862.1045 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for CJB devices
openFDA lists no recalls for product code CJB.
Frequently asked questions
What is FDA product code CJB?
CJB is the FDA product code for chromatographic separation/radioimmunoassay, aldosterone. It is a Class II device, regulated under 21 CFR 862.1045 and reviewed by the Clinical Chemistry panel.
What device class is CJB?
Class II, regulation 21 CFR 862.1045. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code CJB
- Run a recall and safety report across every CJB manufacturer
- Watch product code CJB 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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