Culture Media, Antibiotic Assay
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Guangdong: 2 hold an FDA registration. 1 is a contract manufacturer.
- Guangzhou Nuoning Medical Supplies Co., Ltd. Guangdong, contract manufacturer
- Saferlife Products Co., Ltd. Guangdong, contract manufacturer
What Is FDA Product Code JSA?
Culture Media, Antibiotic Assay is FDA product code JSA, Class 1, 21 CFR 866.2350.
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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