Stanbio Laboratory

Stanbio Laboratory — FDA 510(k) Submissions

Stanbio Laboratory has submitted 47 FDA 510(k) premarket notifications since 1977, of which 47 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Agglutination Method, Human Chorionic Gonadotropin, System, Hemoglobin, Automated, Photometric Method, Iron (non-heme), Colorimetry, Acetaminophen, Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides . Use the specialty filter in the sidebar to narrow results.