Home Access Health Corp.; Premarket Approval of the Home AccessRegister HIV-1 Test System

Streszczenie

The Food and Drug Administration (FDA) is announcing its approval of the application by Home Access Health Corp. (HAHC), Hoffman Estates, IL, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Home Access HIV-1 Test System. After reviewing the recommendation of the Blood Products Advisory Committee (BPAC), FDA's Center for Biologics Evaluation and Research (CBER) notified the applicant, by letter of July 22, 1996, of the approval of the application.