FDA product code MJB: Antigen, Cancer 549
MJB is the FDA product code for antigen, cancer 549. It is a Class III device, reviewed by the Immunology panel. Devices under MJB 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 | Antigen, Cancer 549 |
| Device class | Class III |
| Review panel | IM — Immunology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MJB devices
openFDA lists no recalls for product code MJB.
Frequently asked questions
What is FDA product code MJB?
MJB is the FDA product code for antigen, cancer 549. It is a Class III device, reviewed by the Immunology panel.
What device class is MJB?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MJB
- Run a recall and safety report across every MJB manufacturer
- Watch product code MJB 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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