Abbott Ireland Diagnostics Division

Abbott Ireland Diagnostics Division — FDA 510(k) Submissions

Abbott Ireland Diagnostics Division has submitted 8 FDA 510(k) premarket notifications since 2021, of which 8 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Bromcresol Purple Dye-binding, Albumin, Enzymatic Esterase--oxidase, Cholesterol, Urease And Glutamic Dehydrogenase, Urea Nitrogen, Alkaline Picrate, Colorimetry, Creatinine, Catalytic Methods, Amylase . Use the specialty filter in the sidebar to narrow results.