Henry Schein
Urispec + UA Reader w 4 Promo
Solution, Copper Sulfate for Specific Gravity Determinations
Which Manufacturers in China Make This?
3 of the 5 manufacturers in China registered for this device type are contract manufacturers, able to build to a buyer’s own specification. They are concentrated in Jilin, Guangxi and Shandong.
- Changchun Merydi BIO-Tech Co., Ltd. Jilin
- Changchun Wancheng BIO-Electron Co., Ltd. Jilin, contract manufacturer
- Jilin Hongyi BIO-Tech Co., Ltd. Jilin
- Urit Medical Electronic Co., Ltd. Guangxi, contract manufacturer
- Weihai Kangzheng Medical Equipments Technology Co., Ltd. Shandong, contract manufacturer
What Is FDA Product Code KSL?
Solution, Copper Sulfate For Specific Gravity Determinations is FDA product code KSL, Class 1, 21 CFR 864.9320.
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.