Diagnostica Stago, Inc. - FDA 510(k) Cleared Devices

Diagnostica Stago, Inc. is an industry leader in hemostasis and thrombosis analysis. The company provides coagulation instruments, reagent kits, and related systems for clinical and research laboratories. With a manufacturing facility in Parsippany, US, the company has served the hemostasis laboratory community for over 25 years.

Diagnostica Stago, Inc. has received 16 FDA 510(k) clearances from 16 total submissions since 2001. All submissions focus on Hematology devices. The company's latest clearance in 2026 demonstrates continued innovation and active regulatory engagement in automated multi-parametric analyzers and hemostasis testing reagents.

Recent cleared devices include automated multi-parameter analyzers, calibrators, and specialized hemostasis assays. The STA product line represents the company's core portfolio of coagulation testing systems. These devices support routine analysis and research applications across clinical laboratories worldwide.

Explore the complete regulatory history, device names, product codes, and clearance dates in the 510(k) database.