Oil, Clearing
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are concentrated in Guangdong, Guangxi and Shandong: 3 hold an FDA registration.
- Dongguan Wanjin Industrial Co., Ltd. Guangdong
- Jinan Babio Biotechnology Co., Ltd. Shandong
- Nanning Sixtant Biotechnology Co., Ltd. Guangxi
How Is IJZ Classified?
Oil, Clearing is FDA product code IJZ, Class 1, 21 CFR 864.4010.
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. It is also exempt from most of the quality system regulation.
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