Apparatus, Automated Blood Cell Diluting

What Is FDA Product Code GKH?

Apparatus, Automated Blood Cell Diluting is FDA product code GKH, Class 1, 21 CFR 864.5240.

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 Do the Recalls Say?

The FDA has recorded 2 recalls under this product code since 2009. None was by a company in China. The root causes the FDA records most often are Process control (1) and Device Design (1).

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