Diagnostic Specialties

Diagnostic Specialties — FDA 510(k) Submissions

Diagnostic Specialties has submitted 8 FDA 510(k) premarket notifications since 1981, of which 8 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Glucose Oxidase, Glucose, Tetraphenyl Borate, Colorimetry, Potassium, Kit, Test, Pregnancy, Hcg, Over The Counter, Agglutination Method, Human Chorionic Gonadotropin, Indicator Method, Protein Or Albumin (urinary, Non-quant.) . Use the specialty filter in the sidebar to narrow results.