Centrifuge, Microsedimentation
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Zhejiang and Jiangsu: 7 hold an FDA registration.
- Anji Spenq Industrial Co., Ltd. Zhejiang
- Boen Healthcare Co., Ltd. Jiangsu
- Citotest Labware Manufacturing Co., Ltd. Jiangsu
- Citotest Scientific Co., Ltd. Jiangsu
- Huzhou Junda Industry Co., Ltd. Zhejiang, contract manufacturer
- Ningbo Greetmed Medical Instruments Co., Ltd. Zhejiang
- Zhejiang Lidesen Medical Instrument Co., Ltd. Zhejiang, contract manufacturer
What Is FDA Product Code GHK?
Centrifuge, Microsedimentation is FDA product code GHK, Class 1, 21 CFR 864.5350.
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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