Nanostring Technologies - FDA 510(k) Cleared Devices

Nanostring Technologies, is a life sciences company specializing in spatial biology and gene expression profiling. The company operates with a manufacturing facility in Seattle, US.

Nanostring Technologies received 1 FDA 510(k) clearance from 1 total submission in the Pathology category. The company's first and only clearance was granted in 2013 for the PROSIGNA™ Breast Cancer Prognostic Gene Signature Assay. The company is currently inactive, with no new FDA 510(k) submissions recorded in over a decade.

This regulatory record reflects the company's historical focus on molecular diagnostics and cancer prognostication. Nanostring's cleared device represents a foundational contribution to precision oncology and pathology-based biomarker testing.

For detailed information on device names, product codes, and clearance dates, consult the FDA 510(k) database or contact the company directly.

510(k) submissions have been managed by Veracyte, Inc. as regulatory consultant.