FDA product code MYJ: Device, Mixing And Weighing, Semi-Automated
MYJ is the FDA product code for device, mixing and weighing, semi-automated. It is a Class II device, regulated under 21 CFR 864.9195 and reviewed by the Hematology panel. Devices under MYJ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Device, Mixing And Weighing, Semi-Automated |
| Device class | Class II |
| Regulation | 21 CFR 864.9195 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Recalls for MYJ devices
openFDA lists no recalls for product code MYJ.
Frequently asked questions
What is FDA product code MYJ?
MYJ is the FDA product code for device, mixing and weighing, semi-automated. It is a Class II device, regulated under 21 CFR 864.9195 and reviewed by the Hematology panel.
What device class is MYJ?
Class II, regulation 21 CFR 864.9195. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code MYJ
- Run a recall and safety report across every MYJ manufacturer
- Watch product code MYJ 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.