PMA
P850029: ABBOTT ER-EIA MONOCLONAL DIAG. KIT
FDA PMA · KIT, ASSAY, ESTROGEN RECEPTOR · Abbott Laboratories
Key facts
| PMA number | P850029 |
|---|---|
| Trade name | ABBOTT ER-EIA MONOCLONAL DIAG. KIT |
| Generic name | KIT, ASSAY, ESTROGEN RECEPTOR |
| Applicant | Abbott Laboratories |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | LPJ |
| Approval date | Oct 17, 1988 |
| Docket number | 88M-0368 |
| Notice date | Dec 16, 1988 |
| Establishment registration | 1415939 |
| FEI number | 1415939 |
At a glance
- 1–9 Supplements
- Sep 22, 1999 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- Yes Withdrawn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: