PMA
P820077: AFP MID-PREGNANCY REFERENCE PREPARATION
FDA PMA · CALIBRATOR FOR ALPHA-FETOPROTEIN IN MID-PREGNANCY MATERNAL SERUM · Centers for Disease Control and Prevention
Key facts
| PMA number | P820077 |
|---|---|
| Trade name | AFP MID-PREGNANCY REFERENCE PREPARATION |
| Generic name | CALIBRATOR FOR ALPHA-FETOPROTEIN IN MID-PREGNANCY MATERNAL SERUM |
| Applicant | Centers for Disease Control and Prevention |
| Owner/operator | U.S. GOVERNMENT DEPARTMENT HHS |
| Product code | LTQ |
| Approval date | Nov 30, 1984 |
| Docket number | 84M-0410 |
| Notice date | Jan 3, 1985 |
| Establishment registration | 1050190 |
| FEI number | 1050190 |
At a glance
- None Supplements
- Nov 30, 1984 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- Yes Withdrawn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: