FDA product code MAN: Assay, Interleukin
MAN is the FDA product code for assay, interleukin. It is a Class III device, reviewed by the Immunology panel. Devices under MAN 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 | Assay, Interleukin |
| Device class | Class III |
| Review panel | IM — Immunology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MAN devices
openFDA lists no recalls for product code MAN.
Frequently asked questions
What is FDA product code MAN?
MAN is the FDA product code for assay, interleukin. It is a Class III device, reviewed by the Immunology panel.
What device class is MAN?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MAN
- Run a recall and safety report across every MAN manufacturer
- Watch product code MAN 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.
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