Gas Chromatograph, Carbon-Monoxide
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 JKT Classified?
Gas Chromatograph, Carbon-Monoxide is FDA product code JKT, Class 1, 21 CFR 862.3220.
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.
Name
Record