PMA
P880040: CELLFREE INTERLEUKIN-2RECEPTOR ASSAY KIT
FDA PMA · ASSAY, INTERLEUKIN · Pierce Biotechnology, Inc.
Key facts
| PMA number | P880040 |
|---|---|
| Trade name | CELLFREE INTERLEUKIN-2RECEPTOR ASSAY KIT |
| Generic name | ASSAY, INTERLEUKIN |
| Applicant | Pierce Biotechnology, Inc. |
| Product code | MAN |
| Approval date | Oct 6, 1989 |
| Docket number | 89M-0455 |
| Notice date | Nov 14, 1989 |
At a glance
- 1–9 Supplements
- Aug 7, 1996 Latest supplement decision
- Yes Withdrawn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: