FDA product code KJZ: Martius Yellow
KJZ is the FDA product code for martius yellow. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. Devices under KJZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Martius Yellow |
| Device class | Class I |
| Regulation | 21 CFR 864.1850 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for KJZ devices
openFDA lists no recalls for product code KJZ.
Frequently asked questions
What is FDA product code KJZ?
KJZ is the FDA product code for martius yellow. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is KJZ?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KJZ
- Run a recall and safety report across every KJZ manufacturer
- Watch product code KJZ 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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