Inova Diagnostics, Inc. - FDA 510(k) Cleared Devices

Siemens Healthcare Diagnostics, Inc. is a leading diagnostic device manufacturer based in New York. The company specializes in laboratory diagnostics and clinical chemistry solutions.

The company has received 136 FDA 510(k) clearances from 138 total submissions since its first clearance in 2008. Chemistry devices and immunology assays represent the core focus of its regulatory portfolio. The latest FDA 510(k) clearance in 2026 reflects continued active development and market engagement.

Recent cleared devices include automated chemistry analyzers, immunoassay systems, and specialized diagnostic assays for thyroid, cardiac, and metabolic markers. The company's product portfolio addresses routine clinical chemistry, immunology, and point-of-care testing across hospital and laboratory settings.

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