Apparatus, Electrophoresis, for Clinical Use

How Is JJN Classified?

Apparatus, Electrophoresis, For Clinical Use is FDA product code JJN, Class 1, 21 CFR 862.2485.

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 1 recall under this product code since 2017. None was by a company in China. The root cause the FDA records most often is Device Design (1).

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