FDA product code KJW: Janus Green B
KJW is the FDA product code for janus green b. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. Devices under KJW reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Janus Green B |
| 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 KJW devices
openFDA lists no recalls for product code KJW.
Frequently asked questions
What is FDA product code KJW?
KJW is the FDA product code for janus green b. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is KJW?
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 KJW
- Run a recall and safety report across every KJW manufacturer
- Watch product code KJW 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.