HDE supplement
H990012 S001: TAS ECT TEST
FDA HDE supplement · normal 75 day track · CARDIOVASCULAR DIAGNOSTICS, INC.
Key facts
| Original HDE | H990012 |
|---|---|
| Supplement number | S001 |
| Supplement type | normal 75 day track |
| Reason for the supplement | location change - manufacturer/sterilizer/packager/supplier |
| Trade name | TAS ECT TEST |
| Generic name | Test, ecarin clotting time (ect) |
| Applicant | CARDIOVASCULAR DIAGNOSTICS, INC. |
| Product code | NDV |
| Received date | Feb 5, 2004 |
| Decision date | Aug 31, 2004 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: