PMA supplement
BP130026 S006: PreciseType TM HEA Molecular BeadChip test
FDA PMA supplement · 30-Day Notice · BioArray Solutions, Ltd.
Key facts
| Original PMA | BP130026 |
|---|---|
| Supplement number | S006 |
| Supplement type | 30-Day Notice |
| Trade name | PreciseType TM HEA Molecular BeadChip test |
| Generic name | Molecular erythrocyte typing test |
| Applicant | BioArray Solutions, Ltd. |
| Product code | PEP |
| Received date | Sep 13, 2016 |
| Decision date | Oct 3, 2016 |
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: