PMA
P880032: BIO-RAD CYCLOSPORINE BY HPLC TEST
FDA PMA · HIGH PERFORMANCE LIQUID CHROMATOGRAPHY FOR CYCLOSPORINE · Bio-Rad
Key facts
| PMA number | P880032 |
|---|---|
| Trade name | BIO-RAD CYCLOSPORINE BY HPLC TEST |
| Generic name | HIGH PERFORMANCE LIQUID CHROMATOGRAPHY FOR CYCLOSPORINE |
| Applicant | Bio-Rad |
| Owner/operator | Bio-Rad Laboratories, Inc. |
| Product code | MGS |
| Approval date | Jul 24, 1989 |
| Docket number | 89M-0321 |
| Notice date | Aug 22, 1989 |
| Establishment registration | 2915274 |
| FEI number | 2915274 |
At a glance
- 1–9 Supplements
- Mar 1, 1996 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- No Withdrawn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: