Sebia - FDA 510(k) Cleared Devices

Sebia, is a global specialized in vitro diagnostic (IVD) player providing powerful diagnostic tools for chronic and metabolic diseases. The company operates with a manufacturing facility in Chelsea, US, and serves laboratories worldwide with instruments, tests, and software solutions.

Sebia has received 32 FDA 510(k) clearances from 32 total submissions since 1995, with no denied submissions on record. The company specializes in immunology devices, including capillary electrophoresis and immunofixation technologies. Latest clearance in 2024 confirms active regulatory engagement.

Recent FDA 510(k) cleared devices focus on free light chain (FLC) testing, immunotyping systems, and monoclonal antibody-based assays for oncology applications, particularly multiple myeloma. Sebia's product portfolio includes the Capillarys and MINICAP instrument lines, supported by comprehensive control materials and software platforms.

Explore the full list of device names, product codes, and clearance dates in the 510(k) database to review Sebia's complete regulatory history and cleared device specifications.