I-Stat Corp.

I-Stat Corp. — FDA 510(k) Submissions

I-Stat Corp. has submitted 14 FDA 510(k) premarket notifications since 1989, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrode, Ion Specific, Sodium, Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph, Acid, Lactic, Enzymatic Method, Glucose Oxidase, Glucose, Multi-analyte Controls, All Kinds (assayed) . Use the specialty filter in the sidebar to narrow results.