Chromogenesis, Phenylketones (Urinary, Non-Quant.)
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Jilin.
- Dirui Industrial Co., Ltd. Jilin, contract manufacturer
What Is FDA Product Code CES?
Chromogenesis, Phenylketones (Urinary, Non-Quant.) is FDA product code CES, Class 1, 21 CFR 862.1560.
How Does It Reach the US Market?
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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