PMA
P790025: ABBOTT HBE DIAGNOSTIC KIT
FDA PMA · Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) · Abbott Laboratories
Key facts
| PMA number | P790025 |
|---|---|
| Trade name | ABBOTT HBE DIAGNOSTIC KIT |
| Generic name | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) |
| Applicant | Abbott Laboratories |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | LOM |
| Approval date | Jul 15, 1980 |
| Docket number | 80M-0267 |
| Notice date | Sep 12, 1980 |
| Establishment registration | 1415939 |
| FEI number | 1415939 |
At a glance
- 1–9 Supplements
- Jan 17, 2003 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- Yes Withdrawn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: