System, Hemoglobin, Automated

How Is GKR Classified?

System, Hemoglobin, Automated is FDA product code GKR, Class 2, 21 CFR 864.5620.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Do the Recalls Say?

The FDA has recorded 8 recalls under this product code since 2010. None was by a company in China. The root causes the FDA records most often are Device Design (4), Process control (1) and Nonconforming Material/Component (1).

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