Tube, Sedimentation Rate

What Is FDA Product Code GHC?

Tube, Sedimentation Rate is FDA product code GHC, Class 1, 21 CFR 864.6700.

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.

What Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2010. None was by a company in China. The root cause the FDA records most often is Component change control (1).

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