Enzyme Immunoassay, Tracrolimus

What Is FDA Product Code MLM?

Enzyme Immunoassay, Tracrolimus is FDA product code MLM, Class 2, 21 CFR 862.1678.

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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 1 clearance under this code; the FDA took 758 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 12 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Process control (3), Component design/selection (1) and Device Design (1).

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