Abbott Diagnostics - FDA 510(k) Cleared Devices

Abbott Diagnostics, is a diagnostics company with a manufacturing facility in Mountain View, US. The company specializes in Hematology analyzers and related reagents for clinical laboratory testing.

Abbott Diagnostics received 28 FDA 510(k) clearances from 28 total submissions, with no denied submissions on record. The company's regulatory activity spans from 1981 to 1997, with 71% of submissions focused on Hematology devices. This represents a strong historical track record in automated blood analysis systems.

The company's cleared devices include multi-parameter hematology analyzers, rapid-lyse reagents, and isotonic diluents. Notable product lines include the CELL-DYN series, which encompasses automated analyzers designed for comprehensive blood cell counting and differentiation in clinical settings.

Abbott Diagnostics is inactive in the FDA 510(k) database, with no clearances since 1997. This company profile serves as a historical regulatory record. Explore the complete list of device names, product codes, and clearance dates in the database.