FDA product code MZK: System, Separation, Hematopoietic Stem Cell
MZK is the FDA product code for system, separation, hematopoietic stem cell. It is a Class III device, reviewed by the Hematology panel. Devices under MZK reach the market by PMA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | System, Separation, Hematopoietic Stem Cell |
| Device class | Class III |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MZK devices
openFDA lists no recalls for product code MZK.
Frequently asked questions
What is FDA product code MZK?
MZK is the FDA product code for system, separation, hematopoietic stem cell. It is a Class III device, reviewed by the Hematology panel.
What device class is MZK?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MZK
- Run a recall and safety report across every MZK manufacturer
- Watch product code MZK 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.