Cellient®
Processor for use in preparation of cell blocks from cellular material and tissue fragments in PreservCyt®.
Apparatus, Melting Point, Paraffin
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Guangdong and Shanghai: 2 hold an FDA registration.
- Guangzhou Four E's Scientific Co., Ltd. Guangdong, contract manufacturer
- Shanghai Youding International Trade Co., Ltd. Shanghai
How Is IDT Classified?
Apparatus, Melting Point, Paraffin is FDA product code IDT, Class 1, 21 CFR 864.3010.
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. It is also exempt from most of the quality system regulation.
What Do the Recalls Say?
The FDA has recorded 1 recall under this product code since 2016. None was by a company in China. The root cause the FDA records most often is Labeling mix-ups (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
Name
Record