Acid Hematin
Who Makes This Device Type in China?
3 manufacturers in China hold an FDA registration for this device type, based in Shandong and Shanghai.
- Infitek Co., Ltd. Shanghai
- Labpeak Co., Ltd. Shandong
- Scitek Global Co., Ltd. Shandong
How Is GGF Classified?
Acid Hematin is FDA product code GGF, Class 2, 21 CFR 864.7500.
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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