Pointe Scientific, Inc.,

Pointe Scientific, Inc., — FDA 510(k) Submissions

Pointe Scientific, Inc., has submitted 74 FDA 510(k) premarket notifications since 1981, of which 74 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Assay, Glycosylated Hemoglobin, Diazo Colorimetry, Bilirubin, Hexokinase, Glucose, Catalytic Methods, Amylase, Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides . Use the specialty filter in the sidebar to narrow results.