Enzyme Immunoassay, Phencyclidine
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are concentrated in Zhejiang, Guangdong and Beijing, and 4 other provinces: 16 hold an FDA registration. 5 are contract manufacturers.
- Abon Biopharm (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
- Assure Tech. (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
- Changchun Wancheng BIO-Electron Co., Ltd. Jilin, contract manufacturer
- Co-Innovation Biotech Co., Ltd. Guangdong, contract manufacturer
- Guangzhou Wondfo Biotech Co., Ltd. Guangdong, contract manufacturer
- Guangzhou Decheng Biotechnology Co., Ltd. Guangdong
- Hangzhou Laihe Biotech Co., Ltd. Zhejiang, contract manufacturer
- Hongkong Conlight Medical Group Limited Hong Kong
- Hangzhou AllTest Biotech Co., Ltd. Zhejiang, contract manufacturer
- Hangzhou Biotest Biotech Co., Ltd. Zhejiang, contract manufacturer
- Jcmed Tianjin Import AND Export Co., Ltd. Tianjin
- Prometheus Bio Inc. Zhejiang, contract manufacturer
- Qingdao Hightop Biotech Co., Ltd. Shandong
- Vivachek Biotech (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
- W.h.p.m. Bioresearch & Technology Co., Ltd. Beijing
- Zhejiang Orient Gene Biotech Zhejiang, contract manufacturer
What Is FDA Product Code LCM?
Enzyme Immunoassay, Phencyclidine is FDA product code LCM, unclassified.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.
What Do the Recalls Say?
The FDA has recorded 1 recall under this product code since 2005. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.