HDE
H990012: TAS ECT TEST
FDA Humanitarian Device Exemption · CARDIOVASCULAR DIAGNOSTICS, INC.
Key facts
| HDE number | H990012 |
|---|---|
| Trade name | TAS ECT TEST |
| Generic name | Ecarin clotting time |
| Applicant | CARDIOVASCULAR DIAGNOSTICS, INC. |
| Owner/operator | Tecan Group AG |
| Product code | PBA |
| Approval date | May 11, 2000 |
| Docket number | 00M-1354 |
| Establishment registration | 1037985 |
| FEI number | 1037985 |
At a glance
- 1–9 Supplements
- Aug 31, 2004 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: