Qualitative Chemical Reactions, Urinary Calculi (Stone)
Which Manufacturers in China Make This?
3 manufacturers in China hold an FDA registration for this device type, based in Jilin.
- Changchun Merydi BIO-Tech Co., Ltd. Jilin
- Changchun Wancheng BIO-Electron Co., Ltd. Jilin, contract manufacturer
- Jilin Hongyi BIO-Tech Co., Ltd. Jilin
How Is JNQ Classified?
Qualitative Chemical Reactions, Urinary Calculi (Stone) is FDA product code JNQ, Class 1, 21 CFR 862.1780.
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.
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