Bathophenanthroline, Colorimetry, Iron (Non-Heme)
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Jilin and Shandong: 2 hold an FDA registration.
- Biobase Biodustry(Shandong)Co., Ltd. Shandong
- Dirui Industrial Co., Ltd. Jilin, contract manufacturer
How Is CFM Classified?
Bathophenanthroline, Colorimetry, Iron (Non-Heme) is FDA product code CFM, Class 1, 21 CFR 862.1410.
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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