System, Test, Vitamin D

What Is FDA Product Code MRG?

System, Test, Vitamin D is FDA product code MRG, Class 2, 21 CFR 862.1825.

What Does It Take to Sell It in the United States?

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 2 clearances under this code; the FDA took a median of 143 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 25 recalls under this product code since 2004. None was by a company in China. The root causes the FDA records most often are Device Design (5), Nonconforming Material/Component (5) and No Marketing Application (4).

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