FDA product code MTO: Software, Management, Microplate Assay
MTO is the FDA product code for software, management, microplate assay. It is a Not classified device, reviewed by the Hematology panel. Devices under MTO reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Software, Management, Microplate Assay |
| Device class | Not classified |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for MTO devices
openFDA lists no recalls for product code MTO.
Frequently asked questions
What is FDA product code MTO?
MTO is the FDA product code for software, management, microplate assay. It is a Not classified device, reviewed by the Hematology panel.
What device class is MTO?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code MTO
- Run a recall and safety report across every MTO manufacturer
- Watch product code MTO 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.