Lipase-Esterase, Enzymatic, Photometric, Lipase

How Is CHI Classified?

Lipase-Esterase, Enzymatic, Photometric, Lipase is FDA product code CHI, Class 1, 21 CFR 862.1465.

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 22 recalls under this product code since 2004. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (4), Device Design (2) and Labeling Change Control (1).

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