Roche Diagnostics - FDA 510(k) Cleared Devices

Roche Diagnostics, is a Swiss multinational healthcare company specializing in diagnostic devices and solutions. The company operates its U.S. diagnostics division from Indianapolis.

Roche Diagnostics maintains a strong FDA 510(k) regulatory record with 182 FDA 510(k) cleared devices from 184 total submissions since 2005. The company's portfolio spans chemistry devices, immunology assays, microbiology testing, and hematology systems. The latest clearance in 2026 reflects continued innovation and regulatory engagement.

Recent cleared devices include glucose monitoring systems, electrolyte analyzers, immunoassays for cardiac and infectious disease markers, and integrated laboratory solutions. The cobas pro integrated solutions and Elecsys immunoassay platforms represent core product lines across multiple diagnostic specialties.

Explore the complete regulatory history, including device names, product codes, and clearance dates in the database below.