Epredia
Catalogue number HM430 Sliding Microtome, listed by Shandon Diagnostics Limited, United Kingdom, under Microtome, Sliding. 2 manufacturers in China are registered for this product code.
Microtome, Sliding
Which Manufacturers in China Make This?
2 manufacturers in China hold an FDA registration for this device type, based in Shanghai. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.
- Epredia Laboratory Products Manufacturing (Shanghai) Co., Ltd. Shanghai, contract manufacturer
- Leica Instruments (Shanghai) Co., Ltd. Shanghai, contract manufacturer
How Is KFL Classified?
Microtome, Sliding is FDA product code KFL, Class 1, 21 CFR 864.3010.
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. It is also exempt from most of the quality system regulation.
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