PMA
P970007: IMX TACROLIMUS II ASSAY
FDA PMA · ENZYME IMMUNOASSAY, TRACROLIMUS · Abbott Laboratories
Key facts
| PMA number | P970007 |
|---|---|
| Trade name | IMX TACROLIMUS II ASSAY |
| Generic name | ENZYME IMMUNOASSAY, TRACROLIMUS |
| Applicant | Abbott Laboratories |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | MLM |
| Approval date | Aug 26, 1997 |
| Docket number | 97M-0520 |
| Notice date | Jan 6, 1998 |
| Establishment registration | 1415939 |
| FEI number | 1415939 |
At a glance
- 1–9 Supplements
- Sep 5, 2002 Latest supplement decision
- No Withdrawn
- No 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: