Serim Research Corp. - FDA 510(k) Cleared Devices

Serim Research Corp., develops and manufactures diagnostic test strips based on proprietary dry reagent technology. The company operates a fully integrated research and development and manufacturing facility in Elkhart, Indiana. Since 1988, Serim has specialized in colorimetric chemistries, reagent impregnation, and test strip fabrication for medical and industrial applications.

The company received 27 FDA 510(k) clearances from 27 total submissions, with all submissions resulting in clearance. Serim's cleared devices focus on gastroenterology and urology applications, including test strips for dialysis monitoring, disinfectant potency testing, and blood leak detection. The company's regulatory activity spans from 1990 to 2012, establishing a historical record of successful device submissions.

Serim's product portfolio includes test strips for dialysis centers, high-level disinfectant monitoring in surgical settings, food safety and sanitation applications, and rapid diagnostic testing for Helicobacter pylori infection. The company also offers contract manufacturing, private label products, and custom product development services. Its facility is certified to ISO 9001 and ISO 13485 medical device standards.

This company is inactive, with no FDA 510(k) clearances recorded after 2012. The information presented reflects the historical regulatory record. Explore the device names, product codes, and clearance dates in the full 510(k) database for complete submission details.