FDA product code LKV: Enzyme Immunoassay, Fetal Fibronectin
LKV is the FDA product code for enzyme immunoassay, fetal fibronectin. It is a Class III device, reviewed by the Clinical Chemistry panel. Devices under LKV reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 7 recalls for LKV devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Fetal Fibronectin |
| Device class | Class III |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LKV devices
7 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-11-29.
| Year | Recalls |
|---|---|
| 2017 | 2 |
Frequently asked questions
What is FDA product code LKV?
LKV is the FDA product code for enzyme immunoassay, fetal fibronectin. It is a Class III device, reviewed by the Clinical Chemistry panel.
What device class is LKV?
Class III. Typical premarket route: PMA.
Have LKV devices been recalled?
Yes: 7 product recalls across 2 recall events; the most recent began 2017-11-29.
Next steps
- Run an FDA pathway report with predicate devices for product code LKV
- Run a recall and safety report across every LKV manufacturer
- Watch product code LKV 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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