Stain, Papanicolau

How Is HZJ Classified?

Stain, Papanicolau is FDA product code HZJ, Class 1, 21 CFR 864.1850.

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

What Do the Recalls Say?

The FDA has recorded 2 recalls under this product code since 2002. None was by a company in China. The root cause the FDA records most often is Error in labeling (1).

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