Nanostring Technologies, Inc. is one of 16403 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Nanostring Technologies, Inc. - FDA 510(k) Cleared Devices
Recent clearances: PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
1
Total
1
Cleared
0
Denied
Nanostring Technologies, Inc. specializes in pathology devices and molecular analysis solutions. The company, now part of Bruker Spatial Biology, operates with a registered facility in Seattle, Washington. It develops targeted gene expression profiling and spatial biology platforms for research and clinical applications.
The company received 1 FDA 510(k) clearance from 1 total submission in the pathology category. The clearance was granted in 2014 for the PROSIGNA Breast Cancer Prognostic Gene Signature Assay. Nanostring has not submitted additional 510(k) applications since that time and is considered inactive in the FDA clearance database.
The company's historical focus centered on gene expression profiling and molecular diagnostics. Its cleared assay provided prognostic information for breast cancer patients using targeted RNA analysis. This work established foundational capabilities in precision oncology diagnostics.
Explore the full regulatory record, including device names, product codes, and clearance dates in the 510(k) database.
FDA 510(k) Regulatory Record - Nanostring Technologies, Inc.
1 devices