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Zdrowie i gospodarka · 17/12/1996

FDA Approves Premarket Approval of Bartels ChemoResponse Assay

The US Food and Drug Administration (FDA) has approved the premarket approval application of Bartels Prognostics, Inc. for its ChemoResponse Assay, following the recommendation of the Microbiology Devices Panel. The approval was notified to the applicant on August 1, 1996, by the FDA's Center for Devices and Radiological Health (CDRH).

Source: Federal Register — Food and Drug AdministrationOpen original release →