Helena Laboratories, Corp.

Helena Laboratories, Corp. — FDA 510(k) Submissions

Helena Laboratories, Corp. has submitted 2 FDA 510(k) premarket notifications since 2022, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Abnormal Hemoglobin Quantitation, Alpha-1-antitrypsin Kit, Qualitative Phenotype . Use the specialty filter in the sidebar to narrow results.