FDA product code MTR: Progenitor Cell Enumeration
MTR is the FDA product code for progenitor cell enumeration. It is a Class II device, reviewed by the Hematology panel. Devices under MTR reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Cber
Classification
| Field | Value |
|---|---|
| Device name | Progenitor Cell Enumeration |
| Device class | Class II |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
Recalls for MTR devices
openFDA lists no recalls for product code MTR.
Frequently asked questions
What is FDA product code MTR?
MTR is the FDA product code for progenitor cell enumeration. It is a Class II device, reviewed by the Hematology panel.
What device class is MTR?
Class II. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code MTR
- Run a recall and safety report across every MTR manufacturer
- Watch product code MTR 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.