Stains, Hematology

How Is KQC Classified?

Stains, Hematology is FDA product code KQC, 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 5 recalls under this product code since 2007. None was by a company in China. The root causes the FDA records most often are Employee error (2) and Nonconforming Material/Component (2).

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