Eosin Y

What Is FDA Product Code HYB?

Eosin Y is FDA product code HYB, Class 1, 21 CFR 864.1850.

What Does It Take to Sell It in the United States?

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. It is also exempt from most of the quality system regulation.

What Do the Recalls Say?

The FDA has recorded 3 recalls under this product code since 2010. None was by a company in China. The root cause the FDA records most often is Component design/selection (3).

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