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