Chamber, Slide Culture
Who Makes This Device Type in China?
6 manufacturers in China hold an FDA registration for this device type, based in Jiangsu and Hainan. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.
- Boen Healthcare Co., Ltd. Jiangsu
- Citotest Labware Manufacturing Co., Ltd. Jiangsu
- Citotest Scientific Co., Ltd. Jiangsu
- Cnooc Yonglian Pharmaceutical Innovation (Hainan) Co., Ltd. Hainan
- Conod Medical Co., Limited Jiangsu, contract manufacturer
- Jiangsu NEW Pentastar Medical Products Co., Ltd. Jiangsu
How Is KIY Classified?
Chamber, Slide Culture is FDA product code KIY, Class 1, 21 CFR 864.2240.
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.