PMA
P860015: FLUORO-CEP{R} ESTROGEN ASSAY REAGENT
FDA PMA · KIT, ASSAY, ESTROGEN RECEPTOR · Zeus Technologies
Key facts
| PMA number | P860015 |
|---|---|
| Trade name | FLUORO-CEP{R} ESTROGEN ASSAY REAGENT |
| Generic name | KIT, ASSAY, ESTROGEN RECEPTOR |
| Applicant | Zeus Technologies |
| Product code | LPJ |
| Approval date | Feb 29, 1988 |
| Docket number | 88M-0091 |
| Notice date | May 11, 1988 |
At a glance
- 1–9 Supplements
- Apr 21, 1992 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- Yes Withdrawn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: