Zdrowie i gospodarka · 17/12/1996
Bartels Prognostics, Inc.; Premarket Approval of Bartels ChemoResponse Assay
The Food and Drug Administration (FDA) is announcing its approval of the application by Bartels Prognostics, Inc., Issaquah, WA, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of Bartels ChemoResponse Assay. After reviewing the recommendation of the Microbiology Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of August 1, 1996, of the approval of the application.