FDA product code MHR: Test, Anti-Tumor Cell Susceptibility
MHR is the FDA product code for test, anti-tumor cell susceptibility. It is a Class III device, reviewed by the Microbiology panel. Devices under MHR reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Test, Anti-Tumor Cell Susceptibility |
| Device class | Class III |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MHR devices
openFDA lists no recalls for product code MHR.
Frequently asked questions
What is FDA product code MHR?
MHR is the FDA product code for test, anti-tumor cell susceptibility. It is a Class III device, reviewed by the Microbiology panel.
What device class is MHR?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MHR
- Run a recall and safety report across every MHR manufacturer
- Watch product code MHR 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.