Device, Vein Location, Liquid Crystal

What Is FDA Product Code KZA?

Device, Vein Location, Liquid Crystal is FDA product code KZA, Class 1, 21 CFR 880.6970.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 2 recalls under this product code since 2012. None was by a company in China. The root cause the FDA records most often is Employee error (2).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.