PMA
P970025: PRO-TRAC II TACROLIMUS ELISA KIT
FDA PMA · ENZYME IMMUNOASSAY, TRACROLIMUS · DiaSorin, Inc.
Key facts
| PMA number | P970025 |
|---|---|
| Trade name | PRO-TRAC II TACROLIMUS ELISA KIT |
| Generic name | ENZYME IMMUNOASSAY, TRACROLIMUS |
| Applicant | DiaSorin, Inc. |
| Owner/operator | DiaSorin Inc. |
| Product code | MLM |
| Approval date | Apr 27, 1999 |
| Docket number | 01M-0072 |
| Notice date | Feb 16, 2001 |
| Establishment registration | 2182595 |
| FEI number | 2182595 |
At a glance
- None Supplements
- Apr 27, 1999 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness 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 PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: