Helena Laboratories
Helena Laboratories — FDA 510(k) Submissions
Helena Laboratories has submitted 280 FDA 510(k) premarket notifications since 1978, of which 280 received clearance as substantially equivalent to a predicate device.
The company's most frequent device categories include Assay, Glycosylated Hemoglobin, Test, Qualitative And Quantitative Factor Deficiency, Electrophoretic Separation, Lipoproteins, Electrophoretic, Protein Fractionation, Reagent, Occult Blood . Use the specialty filter in the sidebar to narrow results.
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