FDA product code KTJ: System, Test, Alpha-Fetoprotein, Ria
KTJ is the FDA product code for system, test, alpha-fetoprotein, ria. It is a Class III device, reviewed by the Immunology panel. Devices under KTJ reach the market by PMA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Alpha-Fetoprotein, Ria |
| Device class | Class III |
| Review panel | IM — Immunology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for KTJ devices
openFDA lists no recalls for product code KTJ.
Frequently asked questions
What is FDA product code KTJ?
KTJ is the FDA product code for system, test, alpha-fetoprotein, ria. It is a Class III device, reviewed by the Immunology panel.
What device class is KTJ?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code KTJ
- Run a recall and safety report across every KTJ manufacturer
- Watch product code KTJ 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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