Cholinesterase Test Paper
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 DIG?
Cholinesterase Test Paper is FDA product code DIG, Class 1, 21 CFR 862.3240.
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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