PMA
P880016: ONCOR B/T GENE REARRANGEMENT TEST
FDA PMA · DNA-probe, b and t lymphocyte · Oncor, Inc.
Key facts
| PMA number | P880016 |
|---|---|
| Trade name | ONCOR B/T GENE REARRANGEMENT TEST |
| Generic name | DNA-probe, b and t lymphocyte |
| Applicant | Oncor, Inc. |
| Product code | MAM |
| Approval date | Oct 10, 1989 |
| Docket number | 89M-0456 |
| Notice date | Nov 14, 1989 |
At a glance
- 1–9 Supplements
- Jan 13, 1993 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- No Withdrawn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: