Enzymatic (Glutathione Reductase), Glutathione
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Jilin and Zhejiang: 2 hold an FDA registration.
- Dirui Industrial Co., Ltd. Jilin, contract manufacturer
- Zhejiang Orient Gene Biotech Zhejiang, contract manufacturer
What Is FDA Product Code JLO?
Enzymatic (Glutathione Reductase), Glutathione is FDA product code JLO, Class 1, 21 CFR 862.1365.
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.
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