Preservative, Cytological

What Is FDA Product Code LEA?

Preservative, Cytological is FDA product code LEA, Class 1, 21 CFR 864.4010.

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 4 recalls under this product code since 2012. None was by a company in China. The root causes the FDA records most often are Material/Component Contamination (2) and Process design (1).

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