PMA supplement
BP950002 S027: Home Access HIV-1 Test System
FDA PMA supplement · 135 Day Track for 30 Day Notification · Home Access Health Corporation
Key facts
| Original PMA | BP950002 |
|---|---|
| Supplement number | S027 |
| Supplement type | 135 Day Track for 30 Day Notification |
| Trade name | Home Access HIV-1 Test System |
| Generic name | Hiv testing service |
| Applicant | Home Access Health Corporation |
| Product code | MVZ |
| Received date | Nov 9, 2010 |
| Decision date | Apr 8, 2011 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: