FDA product code KJD: Spinner, Flask
KJD is the FDA product code for spinner, flask. It is a Class I device, regulated under 21 CFR 864.2240 and reviewed by the Pathology panel. Devices under KJD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Spinner, Flask |
| 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 KJD devices
openFDA lists no recalls for product code KJD.
Frequently asked questions
What is FDA product code KJD?
KJD is the FDA product code for spinner, flask. It is a Class I device, regulated under 21 CFR 864.2240 and reviewed by the Pathology panel.
What device class is KJD?
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 KJD
- Run a recall and safety report across every KJD manufacturer
- Watch product code KJD 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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