Home Access Health submits PMA for home-use HIV test system.
This article was originally published in The Gray Sheet
Executive Summary
HOME ACCESS HEALTH SUBMITS PMA FOR HOME-USE HIV TEST SYSTEM and asks FDA to expedite review of the premarket approval application, the Chicago-based start-up announced June 1. Home Access Health Corp., formerly known as Anonymous Test Services, says it submitted the PMA following the mid-March completion of multi-center Phase III clinical trials involving more than 1,200 subjects.
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