Assay, Glycosylated Hemoglobin

What Is FDA Product Code LCP?

Assay, Glycosylated Hemoglobin is FDA product code LCP, Class 2, 21 CFR 864.7470.

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. Chinese applicants hold 1 clearance under this code; the FDA took 379 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 103 recalls under this product code since 2005. None was by a company in China. The root causes the FDA records most often are Material/Component Contamination (37), Process control (14) and Software design (12).

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