Microtome, Cryostat

How Is IDP Classified?

Microtome, Cryostat is FDA product code IDP, Class 1, 21 CFR 864.3010.

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 10 recalls under this product code since 2010. None was by a company in China. The root causes the FDA records most often are Labeling design (6) and Device Design (3).

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