PMA
P990012: ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG
FDA PMA · Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) · Roche Diagnostics Corp.
Key facts
| PMA number | P990012 |
|---|---|
| Trade name | ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG |
| Generic name | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) |
| Applicant | Roche Diagnostics Corp. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | LOM |
| Approval date | Jun 1, 2001 |
| Docket number | 01M-0507 |
| Notice date | Nov 14, 2001 |
| Establishment registration | 9610529 |
| FEI number | 3002806560 |
At a glance
- 10–99 Supplements
- Apr 24, 2019 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: