FDA product code LOK: Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
LOK is the FDA product code for kit, test, alpha-fetoprotein for neural tube defects. It is a Class III device, reviewed by the Immunology panel. Devices under LOK reach the market by PMA; FDA lists no cleared 510(k)s for it. 11 PMA applications cite this product code. FDA has posted 1 recall for LOK devices.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Test, Alpha-Fetoprotein For Neural Tube Defects |
| Device class | Class III |
| Review panel | IM — Immunology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LOK devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2003-06-12.
Frequently asked questions
What is FDA product code LOK?
LOK is the FDA product code for kit, test, alpha-fetoprotein for neural tube defects. It is a Class III device, reviewed by the Immunology panel.
What device class is LOK?
Class III. Typical premarket route: PMA.
Have LOK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2003-06-12.
Next steps
- Run an FDA pathway report with predicate devices for product code LOK
- Run a recall and safety report across every LOK manufacturer
- Watch product code LOK 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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