FDA product code KJE: Spinner System, Cell Culture
KJE is the FDA product code for spinner system, cell culture. It is a Class I device, regulated under 21 CFR 864.2240 and reviewed by the Pathology panel. Devices under KJE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Spinner System, Cell Culture |
| Device class | Class I |
| Regulation | 21 CFR 864.2240 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for KJE devices
openFDA lists no recalls for product code KJE.
Frequently asked questions
What is FDA product code KJE?
KJE is the FDA product code for spinner system, cell culture. It is a Class I device, regulated under 21 CFR 864.2240 and reviewed by the Pathology panel.
What device class is KJE?
Class I, regulation 21 CFR 864.2240. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KJE
- Run a recall and safety report across every KJE manufacturer
- Watch product code KJE 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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