Micromanipulators and Microinjectors, Assisted Reproduction

How Is MQJ Classified?

Micromanipulators And Microinjectors, Assisted Reproduction is FDA product code MQJ, Class 2, 21 CFR 884.6150.

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 2016. 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.