Trace America, Inc.

Trace America, Inc. — FDA 510(k) Submissions

Trace America, Inc. has submitted 22 FDA 510(k) premarket notifications since 1988, of which 22 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzymatic, Carbon-dioxide, Nadh Oxidation/nad Reduction, Alt/sgpt, Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, Ldl & Vldl Precipitation, Hdl, Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides . Use the specialty filter in the sidebar to narrow results.