FDA product code MXT: Device, Accessory, Cooling Plate For Tissue Embedding Station
MXT is the FDA product code for device, accessory, cooling plate for tissue embedding station. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Clinical Chemistry panel. Devices under MXT reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Device, Accessory, Cooling Plate For Tissue Embedding Station |
| Device class | Class I |
| Regulation | 21 CFR 864.3010 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for MXT devices
openFDA lists no recalls for product code MXT.
Frequently asked questions
What is FDA product code MXT?
MXT is the FDA product code for device, accessory, cooling plate for tissue embedding station. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Clinical Chemistry panel.
What device class is MXT?
Class I, regulation 21 CFR 864.3010. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code MXT
- Run a recall and safety report across every MXT manufacturer
- Watch product code MXT 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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